Buying a Cleared Device Business: Verify the 510(k) Ownership Chain

Suppose your organization—a regional distributor group, an OEM/ODM private-label buyer, or a medical-device manufacturer expanding its US portfolio—is negotiating to buy a small cleared-device business or acquire the US rights to a sterile single-use product line. The seller's pitch deck features a six-digit K number and a reassuring summary: “FDA 510(k)-cleared, fully transferable asset, no new FDA submission required—we will notify the FDA right after closing.”

Then your regulatory team opens the public databases. The Applicant named in the FDA 510(k) Premarket Notification database is a corporate entity from eight years ago that is not the seller. An overseas contract manufacturer actually produces and sterilizes the device. The seller cannot immediately locate the complete original 510(k) submission or the internal engineering evaluations for three component updates made since clearance. And when you ask what exact form the seller plans to file to 'notify the FDA of the transfer', the seller points to routine annual registration.

That scenario is not an edge case. Brokers openly advertise a market for buying, selling, licensing and transferring existing clearances—mdi Consultants, for example, runs a “510(k) Marketplace” where holders can post unused 510(k)s for sale¹⁴. FDA itself writes in its June 5, 2025 draft guidance, Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers (document GUI00001808, docket FDA-2024-D-1528), that it “commonly receives requests from individuals noting that a 510(k) clearance has been transferred to that individual from a previous 510(k) holder, and asking FDA to update the information”—and that it is not required to do so¹. The broker reference shows that such transactions happen; it is not a recommendation, and a marketplace listing says nothing about whether a clearance still fits the device being sold.

Before evaluating whether a 510(k) clearance can validly transfer in a transaction, your team must first confirm that the underlying K number is genuine, covers the exact device models and product code quoted, and represents a Substantially Equivalent decision rather than a mere facility registration. Our step-one companion report—our five-check verification workflow for checking a K number and telling clearance, registration, and listing apart—covers that baseline verification in full. This Buyer Guide begins where that first check ends: proving who legally holds the 510(k) today, reconciling the four records that expose a broken ownership chain, executing the post-closing FURLS, label, and GUDID handovers on time, and drafting the purchase-agreement schedules that prevent you from buying an unusable clearance.

What Actually Transfers When a 510(k) Changes Hands — and What Never Does?

To audit a 510(k) acquisition or licensing deal, separate commercial property law from FDA administrative procedure. On June 5, 2025, FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued the Level 1 draft guidance Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers; the notice of availability is at 90 FR 23937 (document 2025-10238), and the comment period closed August 4, 2025¹, ³. On 14 October 2026 the FDA guidance catalog still lists it as a draft that is not for implementation². It is useful to buyers because it sets out how FDA reads the binding rules in 21 CFR Parts 807, 801 and 830 when a clearance changes hands. Haynes Boone notes that an earlier December 2014 draft on the same topic was withdrawn before it was finalized¹³, so treat the 2025 text as FDA's current thinking rather than settled procedure.

Why Ownership Transfer Alone Does Not Require a New 510(k)

Under section 510(k) of the FD&C Act and 21 CFR 807.81(a), a person required to register must submit a premarket notification at least 90 days before beginning commercial distribution of a device that (1) is being introduced into commercial distribution for the first time in the sense that it is not substantially equivalent to a pre-1976 or reclassified device (807.81(a)(1)); (2) is being introduced into commercial distribution for the first time by a person required to register (807.81(a)(2)); or (3) is a device the person already distributes or is reintroducing but is about to change or modify significantly in design, components, method of manufacture or intended use (807.81(a)(3))⁷.

Why doesn't a buyer trigger 807.81(a)(2) as a new person introducing the device? In Question 4 of the draft—citing 807.81(a) and the 1977 rulemaking preamble at 42 FR 42523—FDA says that when a cleared 510(k) is sold or transferred and the device is not significantly changed, the new holder does not need a new 510(k) if it would not be proposing “to begin the introduction or delivery for introduction into interstate commerce for commercial distribution” of a device¹. There is no FDA transfer application, form, notice letter or approval step for the transfer itself¹, ¹³. Haynes Boone reads the condition as requiring a new 510(k) where the new holder would be introducing the device into commercial distribution for the first time¹³; if the clearance covers a device that was never marketed, get a regulatory opinion before relying on it.

The Singular-Holder Rule: Only One Entity Can Own a 510(k) at a Time

The most dangerous misconception in distribution and private-label deals is that a seller can “transfer” or “co-assign” a 510(k) to a buyer while continuing to market the same device under the same K number—or license one K number to several regional buyers as “co-holders”. Question 2 of FDA's draft takes the opposite view:

“Because there can only be one entity proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device, FDA believes there can be only one 510(k) holder for a device at a time.”— U.S. Food and Drug Administration, Draft Guidance: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers (GUI00001808, June 5, 2025), Question 2

The definitions section makes the same point: for purposes of the guidance, the 510(k) holder “is a singular owner”¹. Squire Patton Boggs adds the transaction consequence: FDA has historically not allowed two companies to manufacture the same device under one clearance, so where a holder licensed manufacturing rights but kept manufacturing itself, FDA has historically required the licensee to obtain its own 510(k); buyers therefore usually seek an exclusive transfer and the seller's agreement to stop manufacturing¹¹. When several brands sell one cleared device without a new 510(k), one party stays the holder (as specification developer or manufacturer) and the others act either as distributors that only add their own name—a distributor placing a device under its own name is exempt from premarket notification when another person filed the 510(k) (807.85(b)(2))—or as registered relabelers or repackagers that list the holder's K number (807.25(g)(4))¹, ⁷. On the seller side, a previous holder that stops performing an activity on the device must update its listing, and one that discontinues commercial distribution must discontinue the listing (807.28(a), (d)); it stays listed only for an activity it still performs, such as contract manufacturing for the buyer¹, ⁷.

Why the Public 510(k) Database Cannot Prove Who Owns the Clearance Today

In many asset purchases—a patent, a trademark, a parcel of land—a public registry records assignments, so a buyer can check the chain of title independently. The FDA 510(k) Premarket Notification database is a record of premarket decisions, not a title registry. FDA's draft says it commonly receives requests to update information after a transfer, that meeting registration and listing requirements is the owner or operator's responsibility, and that FDA is not required to update registration or listing information in response to such notifications¹. Practitioners at Hyman, Phelps & McNamara state the database consequence plainly:

“While it is true the new 510(k) holder can electronically update the device listing and establishment registration, unfortunately, the 510(k) database does not get updated.”— Hyman, Phelps & McNamara, FDA Law Blog, “Whose 510(k) Is It Anyway?” (July 25, 2025)

This administrative design creates two opposite traps for buyers and supplier-qualification teams¹, ¹²:

• Trap 1 — Assuming the Database Applicant Still Owns the Clearance: If Seller A is the original Applicant named in the 510(k) database from 2019, Seller A can print out the public database page and the original 2019 Substantial Equivalence letter even if Seller A sold the 510(k) in a distressed asset sale in 2022. Because the 510(k) database entry is not updated after a transfer, the database alone cannot prove that Seller A has not already assigned the clearance to someone else.
• Trap 2 — Assuming a Different Applicant Name Means the Seller Is Unrelated: Conversely, if Seller B acquired a cleared device line in 2021 from Original Applicant X, the 510(k) database will still display Original Applicant X in the Applicant field today. That mismatch is normal after a valid transfer—provided Seller B holds the unbroken chain of contractual assignments and currently lists the original K number in FDA's Establishment Registration and Device Listing database (FURLS/DRLM).

How do you link today's holder to the historical K number? Through registration and listing. Every listing for a 510(k)-cleared device must include the FDA-assigned premarket submission number (807.25(g)(4)), so the public Establishment Registration & Device Listing database shows which owners or operators list that number and for which activities¹, ⁷, ¹⁵. Two practical limits apply. FDA's public search form has no premarket-submission-number field (HPM's practitioners call for one), so either search by product code, proprietary name or owner/operator and read each listing, or query openFDA's device registration-and-listing data, which exposes a k_number field¹², ¹⁵, ¹⁶. And FDA says public registration and listing updates are generally completed weekly, with a delay between upload and public display¹⁵.

The Four-Record Check: Clearance, Registration and Listing, GUDID, and the Label

Because no single public screen certifies current 510(k) title, a buyer or distributor due-diligence lead must triangulate ownership across four regulatory records—plus the contract and change files behind them—before signing a term sheet or releasing escrow. Each record answers a different question, and specific mismatches reveal whether you are looking at a clean prior transfer, a contract-manufacturing arrangement, an unrecorded relabeling operation or a broken chain of title. FDA's GUDID guidance itself expects device identification data to “align and match” across GUDID and other submissions, including registration and listing⁴.

Decoding Establishment Roles: Who Must List the K Number in FURLS?

When you look up a K number in registration and listing data you will often see more than one company. That does not automatically mean several companies claim the 510(k). Under 21 CFR 807.20(a) and 807.25(g)(4)—summarized in Questions 1 and 3 of FDA's draft—several supply-chain roles must register and list a cleared device using the holder's 510(k) number¹, ⁷:

• Specification developer: initiates specifications for a device that a second party manufactures for the specification developer's own commercial distribution (807.3(d)(3), 807.20(a)(1)). An asset-light brand owner that holds a 510(k) and outsources production typically lists in this role; FDA's draft notes that the specification developer, not the contract manufacturer, submits the 510(k)¹, ⁷.
• Manufacturer and remanufacturer: a manufacturer makes, by chemical, physical, biological or other procedures, an article that meets the definition of a device (807.3(d)). The draft's remanufacturer footnote cites the former 21 CFR 820.3(w); under the Quality Management System Regulation (QMSR) effective February 2, 2026, the definition sits in 820.3(a)¹, ⁹.
• Contract manufacturer and contract sterilizer: sterilizes or otherwise makes a device for or on behalf of a specifications developer or any other person (807.20(a)(2)). Both list the device using the holder's K number even though neither holds the 510(k)¹, ⁷. For partner diligence, see our contract manufacturing partner qualification guide.
• Repackager and relabeler: repackaging, or changing the container, wrapper or labeling in furtherance of distribution, counts as manufacture (807.3(d)(1), 807.20(a)(3)). FDA's draft definitions exclude a firm that only places finished packs in shipping containers, and a relabeler does not include a firm that merely adds its own name to otherwise unchanged labeling¹, ⁷.
• Initial importer: any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale, without repackaging or relabeling (807.3(g)). Initial importers register and may meet their listing obligation by submitting the manufacturer's name and address (807.20(a)(5)). Foreign establishments making devices imported into the United States must register and list in their own right (807.40(a))¹, ⁷.

Who sits outside registration and listing? Part 807 does not apply to a wholesale distributor that does not manufacture, repackage, process or relabel the device (807.20(c)), and a distributor that places a device under its own name—with the label qualified by a phrase such as “Distributed by ___” or “Manufactured for ___” (801.1(c))—is exempt from premarket notification when another person filed the 510(k) (807.85(b)(2))⁷, ¹⁷. Initiating specifications is itself a manufacturing activity (807.3(d)(3)), so a “private label” company that sets the device specifications is a specification developer, not an exempt distributor. If your seller has only ever acted as a distributor while an overseas factory lists the K number as manufacturer under its own specifications, the factory—not the seller—is the likely holder, and the seller may have nothing to sell but distribution rights.

What Must Happen in the First 30 Days After Closing?

When a seller says, “We will notify FDA of the 510(k) transfer after closing,” translate that promise into the mechanisms in 21 CFR Part 807 and Part 830. Because FDA has no transfer-notification form, the new holder notifies FDA indirectly—Haynes Boone's phrase—through registration, listing, the seller's listing update and GUDID submissions, each on its own clock¹, ⁴, ⁷, ⁸, ¹³.

One compliance-vendor listing guide in current search results says listing must be completed “within 5 days” of starting device operations. That figure does not appear in 21 CFR Part 807: the regulation's clocks are 30 days for initial registration and listing (807.22(a)) and for changes to registration information (807.22(b)(2)), the October 1–December 31 annual review (807.22(b)(1), (3)), before import for foreign listings (807.28(c)) and 10 business days for a foreign establishment's US agent changes (807.40(b)(3))¹, ⁷. GUDID adds its own dates. The calendar below orders the clocks by the event that starts each one:

1. The Buyer's 30-Day FURLS Registration and Listing Rule — and the Foreign Import Exception

Under 21 CFR 807.22(a), an owner or operator that has not previously entered into an operation described in 807.20(a) must register within 30 days after entering into that operation and submit device listing information at that time—including the original 510(k) number required by 807.25(g)(4)¹, ⁷. If the buyer is already registered, the 30-day initial clock does not restart: the buyer must add a listing for a premarket submission number it does not currently list (807.28(b)(2)) and report it no later than the October–December review, although listing changes may also be made at other times, such as when a device is introduced into commercial distribution (807.22(b)(4))⁷. List at the time of the change: waiting for the annual window leaves the public record pointing only to the seller. Separately, changes to registration information listed in 807.25(b)—establishment name and address, owner/operator and official-correspondent contact details, and trade names—must be updated within 30 days (807.22(b)(2))⁷.

Buyers that acquire or move production to a foreign establishment get no post-shipment grace period. All device listings for foreign establishments must be submitted before the device may be imported or offered for import (807.28(c)), and no device may be imported unless it is listed and made at a registered foreign establishment (807.40(c))⁷. If the foreign establishment's United States agent name, address or phone number changes during the transaction, the establishment or the agent must report it within 10 business days (807.40(b)(3))⁷.

2. The Seller's Delisting Duty and the Adulteration / Misbranding / Recall Risk

Acquiring a 510(k) is a two-sided listing transaction. While the buyer adds the listing citing the original K number, the previous holder must update its listing when it ceases an activity on the device (807.28(a)) and discontinue the listing if it discontinues commercial distribution (807.28(d))—unless it stays in the supply chain in another listed role, such as contract manufacturer for the buyer¹, ⁷, ¹³.

What if the buyer and seller get these updates wrong? FDA's draft points to two consequences¹:

• Adulteration and misbranding exposure: in Question 5 FDA states, “If you fail to register, list, update GUDID information, or submit a marketing application as required, your device might be considered adulterated and/or misbranded,” citing FD&C Act sections 501(f)(1)(B), 502(a)(1), 502(o) and 502(t)(2)¹. Section 502(o) covers a device made in an establishment not duly registered under section 510 or not included in a required list; 501(f)(1)(B) is the adulteration provision for a class III device without a required approved application; 502(a)(1) covers false or misleading labeling; and 502(t)(2) covers failure to furnish information required under section 519.
• Missed recall contact: FDA notes that it may use FURLS/DRLM in its postmarket surveillance to identify firms, including “to timely notify a firm of the need to begin immediately a recall of a device that presents a risk of illness or injury” (citing 21 CFR 7.45(a), (b))¹. If the seller's stale registration remains the only link to the K number, or the buyer never lists, that notice can go to the wrong company. For how sterile-device recalls develop, see our FDA recall evidence map and supplier-control playbook.

What Belongs in the October–December Annual Listing Window?

Even if your company is already a registered manufacturer or specification developer—so 807.22(a) does not apply—buying a 510(k) creates a reporting duty in FDA's annual registration and listing window.

Under 21 CFR 807.22(b)(1) and (3), every registered owner or operator must, between October 1 and December 31 of each fiscal year, complete annual registration and review its device listings, reporting changes, deletions and any new listings not previously reported⁷. FDA's draft applies this to transfers: the new holder must use that window to report new listings, “including any devices that are the subject of the newly acquired 510(k) clearances”¹. The same review is the backstop for the seller: Squire Patton Boggs notes that a previous holder's listing update is due in the October–December window, though it may be made when the change happens¹, ¹¹.

For deals closing in the fourth quarter, that makes the annual review a closing deliverable: confirm before December 31 that the buyer's annual registration and listing review includes the acquired K number and that the seller's listing update or discontinuation is filed in the same window.

Labels, UDIs, and GUDID: The Handover Most Deals Forget

Most legal alerts on the draft stop at registration and listing. In operational diligence, the harder post-closing work sits in device labeling (21 CFR Part 801) and the Global Unique Device Identification Database (GUDID, 21 CFR Part 830). If a buyer ships post-closing inventory before reconciling the labeler identity, device identifier and GUDID record, the label, the GUDID company name and the listing can point to three different companies—the opposite of FDA's expectation that device identification data align across GUDID and registration and listing⁴.

1. Updating the Name and Place of Business on the Label (21 CFR 801.1)

Under 21 CFR 801.1(a), the label of a device in package form must specify conspicuously the name and place of business of the manufacturer, packer, or distributor; under 801.1(c), where the device is not manufactured by the person named on the label, the name must be qualified by a phrase that reveals the connection—such as “Manufactured for ___”, “Distributed by ___” or other wording that expresses the facts¹⁷.

FDA's draft notes that a transfer may require label updates, including the name and place of business of the manufacturer, packer or distributor¹. Units the buyer distributes under its own name need labels that state those facts accurately¹⁷. If the deal includes finished inventory already labeled with the seller's name and UDI, the purchase agreement should include an inventory sell-through and transition clause stating who remains the responsible labeler for those pre-closing lots.

2. GUDID's Mergers-and-Acquisitions Limitation, New DIs, and the 'Previous DI' Link

Under 21 CFR 830.300, the labeler of a device must provide GUDID information for each version or model required to bear a unique device identifier (UDI)⁸. FDA's draft reminds new holders that labelers must submit timely GUDID updates¹, and FDA's December 17, 2024 Global Unique Device Identification Database (GUDID) guidance explains the mechanics that catch unprepared buyers⁴:

1. GUDID does not yet automate M&A record moves: the guidance lists “account changes related to mergers/acquisitions that may impact DI records” among changes to raise with FDA's UDI Help Desk, explains that the “current version of GUDID has not implemented capability to handle all use-cases surrounding mergers/acquisitions,” and asks firms to make contact when they anticipate such a deal (p. 13)⁴. Each DI record is tied to a Labeler DUNS number, from which GUDID pulls the company name that should match the label, and a Labeler DUNS number, once used, cannot be reused in any other GUDID account (p. 9)⁴. Put the Help Desk contact on the pre-closing plan rather than discovering the limitation after closing.
2. When a new DI is needed: a new device identifier is required for a new version or model (830.50) and when a device is relabeled, together with a record linking the prior DI to the new one (830.60)⁸. GUDID's Previous DI field exists for identifiers reassigned for reasons other than physical-specification or indication changes; FDA's example is a merger or acquisition “where the acquiring company might decide to assign a new device identifier” (p. 14)⁴. HPM's practitioners add that brand or model name changes on the label likely require a new UDI¹². Which attributes force a new DI is set by the “New DI trigger” designations in FDA's GUDID Data Elements Reference Table; check your planned label against it before artwork is approved.
3. Submission timing: under 830.330(b), updated information that appears on the label must be submitted no later than the date a device is first labeled with it, and information that does not appear on the label within 10 business days of the change (a GMDN code, for example)⁸. Once a DI record is published, a seven-calendar-day grace period starts the next day; afterwards New DI trigger attributes cannot be edited, and premarket submission numbers can be added but not edited or deleted, except through an unlock procedure FDA expects to be extremely rare (p. 20)⁴. FDA has also announced that it will remove FDA Preferred Term codes from GUDID, leaving GMDN codes as the nomenclature⁴, ⁵.
4. Public AccessGUDID will not show the listing link: FDA names the FDA Listing Number and the company physical address among the attributes not released to public users of AccessGUDID and openFDA (p. 30), while GUDID itself accepts only a valid FDA Listing Number (p. 15)⁴. Ask the seller for a GUDID export or screenshot showing the FDA Listing Number and premarket submission number for each DI, and match them to its FURLS listing.

For buyers managing UDI obligations across multiple jurisdictions simultaneously, compare this handover against our US GUDID, EU EUDAMED, and China NMPA private-label UDI submission matrix.

When Does the Deal Trigger a New 510(k) Instead?

The rule that a 510(k) transfer requires no new premarket submission holds only if the transferred device is not significantly changed or modified¹. In real acquisitions and licensing deals, buyers rarely leave everything untouched: they move assembly to their own cleanroom, substitute a medical-grade polymer resin or adhesive to match their existing supply chain, switch ethylene oxide (EO) sterilization contractors, or broaden marketing claims on the website. Under 21 CFR 807.81(a)(3) and FDA's October 25, 2017 final guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device⁷, ¹⁰, any change that could significantly affect the safety or effectiveness of the device—or any major change or modification in the intended use of the device—requires a new 510(k) submission at least 90 days before commercial distribution.

Equally dangerous is discovering after closing that the seller already modified the device years ago without submitting a needed 510(k) or documenting a valid 'Letter to File'¹¹, ¹². If the product currently rolling off the seller's production line no longer matches the device cleared in the 510(k), the buyer inherits an unapproved modification from Day 1. Use the decision table below during pre-signing technical due diligence:

For engineering and quality teams planning to move a newly acquired device line into a different factory after closing, review our step-by-step QMSR / ISO 13485 design transfer and change-control checklist to structure the DHF-to-DMR handover and change classification.

What Should the Purchase Agreement Force Across?

Because FDA neither polices private asset sales nor keeps a title registry, the asset purchase agreement, stock purchase agreement or exclusive license is the instrument that proves your title and equips you to keep making the device lawfully. Two practical warnings from FDA's draft and transaction practice should shape the schedules¹, ¹¹, ¹²:

1. Why FDA's FOIA Route Is an Emergency Fallback — Not a Substitute for Seller File Delivery

In Question 5 of the draft, FDA says an entity that wants a copy of a 510(k) may ask the prior owner for all documents or submit a Freedom of Information Act (FOIA) request, and that CDRH posts 510(k) records previously released through FOIA in the 510(k) database, which offers a “Redacted FOIA 510(k)” filter¹, ⁶.

Treat that as a fallback. HPM's practitioners advise purchasers to receive a complete copy of the 510(k), including all correspondence with FDA, as part of the transaction, warning that a FOIA request can take a significant amount of time—especially after cuts to FDA's FOIA staff¹². A FOIA copy is also a public-release copy: Part 807 itself carves trade secret and confidential commercial information, as defined in 21 CFR 20.61, out of what must be made available about a 510(k)⁷, and CDRH's posted copies are redacted. The specifications and test details you need to judge future changes under 807.81(a)(3) are exactly what such a copy may lack. Do not close on a promise that the file can be pulled from FDA later.

2. The Quality-System Record Gap: Transferring the DMR, DHF, and QMSR Medical Device File

Squire Patton Boggs flags a consideration the draft does not mention: the transfer of records, particularly device master records containing device, manufacturing-process, quality, packaging, labeling, installation, maintenance and servicing specifications (citing the former 21 CFR 820.181), plus the other records the buyer needs to keep manufacturing and distributing the device compliantly¹¹. Squire wrote before February 2, 2026, when FDA's Quality Management System Regulation (QMSR; final rule 89 FR 7496) took effect and incorporated ISO 13485:2016 by reference⁹.

Under the QMSR, FDA inspects against ISO 13485:2016 as incorporated by 21 CFR Part 820—including the medical device file in clause 4.2.3, which broadly corresponds to the former device master record; design and development files under clause 7.3 for class II, class III and listed class I devices (820.10(c)); the complaint, servicing and UDI record content required by 820.35; and the labeling and packaging controls in 820.45⁹. Ask for both the legacy DMR, DHF and DHR records and the current medical device file before closing.

Where VEMERIX Fits — and Where Due Diligence Still Begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

VEMERIX does not sell 510(k) assets and does not claim US FDA clearance for its products. Its Disposable Circumcision Stapler and single-use medical laser fiber are registered with China's National Medical Products Administration (NMPA), and the Auto-Circumcision Ring is CE-marked; neither NMPA registration nor CE marking confers US marketing authorization.

Where VEMERIX can fit is the step after a deal. A buyer that acquires a cleared device and wants a new OEM/ODM manufacturing partner faces the site-change evaluation in Table 3, not a paperwork update—and any partner, including VEMERIX, should be qualified against your specifications and change-control file before production moves. For that discussion, the quality and compliance page summarizes Medison's ISO 13485 system and manufacturing base, the downloads page holds product catalogues, and the contact page routes OEM/ODM and technical-documentation requests.

Frequently Asked Questions (FAQ)

Does FDA have to approve or register the transfer of a 510(k)?

No. Neither Part 807 nor FDA's draft guidance provides a transfer approval, form or notice; Haynes Boone summarizes that no specific form or notice letter must be submitted and no FDA approval is required¹, ¹³. A new 510(k) is needed if the device is significantly changed (807.81(a)(3)) or, on Haynes Boone's reading, if the new holder would be introducing it into commercial distribution for the first time⁷, ¹³. In practice, FDA sees the change through the buyer's registration and listing citing the original K number (807.25(g)(4)) and the seller's listing update or discontinuation (807.28(a), (d))¹, ⁷.

Can two companies hold the same 510(k) after a licensing deal?

Not in FDA's view. Question 2 of the draft says FDA believes there can be only one 510(k) holder for a device at a time¹, and Squire Patton Boggs notes that where a holder licensed manufacturing rights but kept manufacturing, FDA has historically required the licensee to obtain its own 510(k)¹¹. A holder that wants another brand to sell the device without transferring the clearance stays the holder, while the partner acts as a distributor that adds its own name (exempt from premarket notification under 807.85(b)(2)) or as a registered relabeler or repackager listing the holder's K number⁷.

The applicant name in the 510(k) database is not the seller — is that a problem?

Not necessarily. FDA is not required to update records in response to transfer notifications, and practitioners report that the 510(k) database keeps the original applicant¹, ¹². When the seller is not the applicant of record, verify two things before closing: (1) that the seller currently lists the K number as manufacturer or specification developer in registration and listing data, and (2) the signed chain of assignments from the original applicant to the seller.

How do I get a copy of the actual 510(k) file if the seller cannot find it?

FDA's draft says you may ask the prior owner for all documents or submit a Freedom of Information Act (FOIA) request, and that CDRH posts 510(k) records previously released through FOIA in the 510(k) database¹, ⁶. Because FOIA can take significant time and a public-release copy omits confidential commercial information, make delivery of the complete 510(k), FDA correspondence and post-clearance change evaluations a closing condition⁷, ¹².

Does a contract manufacturer or relabeler need their own 510(k) after the deal?

Not for the same unchanged device. FDA's draft (Questions 1 and 3) says anyone required to list a cleared device—including contract manufacturers, contract sterilizers, repackagers and relabelers—must list it using the holder's 510(k) number, and that the specification developer, not the contract manufacturer, submits the 510(k)¹, ⁷. A party that significantly changes the device's design, components, method of manufacture or intended use is in a different position (807.81(a)(3)).

What happens if the buyer forgets to register and list within 30 days?

Under 21 CFR 807.22(a), a buyer not previously registered must register and list within 30 days after entering a covered operation, and foreign establishments must be listed before import (807.28(c))⁷. Missing the clock puts the establishment in “failed to register” or “failed to list” status (807.22(c)), and FDA's draft warns that failing to register, list or update GUDID information can leave the device adulterated and/or misbranded; FDA also notes it may use registration and listing data to notify firms of urgent recalls¹, ⁷.

Does moving production to our own factory require a new 510(k)?

Not automatically, but the move must be evaluated under 21 CFR 807.81(a)(3) and FDA's October 2017 guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device¹⁰. If the new facility makes the device to the same specifications with equivalent equipment, materials and validated processes, and the documented evaluation shows the change could not significantly affect safety or effectiveness, the manufacturer records that rationale and implements the transfer through change control and process validation (ISO 13485 clauses 7.3.9 and 7.5.6, applied by Part 820)⁹, ¹⁰. If the move changes the sterilization method, critical materials or manufacturing technology in a way that could significantly affect safety or effectiveness, a new 510(k) is required.

Is the June 2025 FDA guidance final law yet?

No. On 14 October 2026 the FDA guidance catalog still lists Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers (GUI00001808, issued June 5, 2025, docket FDA-2024-D-1528) as a draft that is not for implementation¹, ². Haynes Boone notes FDA withdrew a December 2014 draft on the same topic before finalizing it¹³. Even final guidance describes FDA's current thinking and does not itself create legally enforceable responsibilities, but the statutory and regulatory provisions the draft cites—including FD&C Act sections 501, 502 and 510 and 21 CFR Parts 801, 807, 820 and 830—are in force¹.