A 510(k) can change hands. No rule says how.

A company sells a product line. The asset purchase agreement assigns every regulatory filing that goes with it, including a 510(k) clearance that took eighteen months and a user fee to earn. The buyer now owns the clearance. Nothing in Title 21 says what that sentence actually requires — not a form, not a filing, not a letter FDA has ever agreed to accept as the record of the change. FDA tried to write that rule once, in 2014, and never finished. In June 2025 it tried again.

The pathway that already has one

A PMA’s approval doesn’t move quietly. FDA’s own PMA Frequently Asked Questions page walks through what a transfer of ownership requires: the former owner sends FDA a letter stating that all rights have passed, the new owner takes on the conditions of approval, and — if the change would otherwise need one — a PMA supplement under 21 CFR 814.39 has to go in before the device ships under new ownership. The PMA number stays the same, but the record of who holds it moves through a channel FDA already built for exactly this.

A 510(k) clearance has no equivalent channel. There is no CFR section titled “transfer,” no supplement type for it, and no letter FDA has committed to filing anywhere against the original K-number. The only federal requirement that actually touches a 510(k) changing hands is 21 CFR 807.22, and it wasn’t written for this: it is the same annual establishment registration and device listing rule every manufacturer already owes FDA, applied to a new owner who now has to list the device under its own name.

FDA tried once before

In December 2014, FDA issued a draft Q&A guidance addressing this exact gap — whether a new 510(k) is needed when a cleared device changes ownership, and how the transfer should be reflected. The draft recommended that both the old and new establishments update their registration and listing to show the change. It was never finalized. A question regulatory counsel had been asking informally for years got an answer in draft form, and the draft itself quietly stalled.

The 2025 draft, and what it actually resolves

On June 5, 2025, FDA published a new draft — Transfer of a Premarket Notification (510(k)) Clearance: Questions and Answers — reopening the same question eleven years later. Its position: if the device itself hasn’t been significantly changed or modified, the new owner does not need a new 510(k). The transfer notice is not a separate filing; it is the registration and listing update every establishment already has to file, with the new owner required to carry the original clearance number forward on its own listing rather than file as if the device had never been cleared. FDA does not countersign the change or add a transfer record to the public 510(k) database. The comment period closed August 4, 2025. As of this writing, the guidance is still a draft.

Two guidance attempts, eleven years apart, to answer a question the regulation itself has never addressed — and the answer both times is the same workaround: file a listing update and carry the old number with you.

The practice

Because FDA keeps no transfer record, the only proof that a 510(k) actually changed hands is whatever the parties to the deal kept themselves — the assignment language in the purchase agreement, the dated correspondence, the updated listing filed under the new owner’s own registration. A predicate search, a competitive teardown, or a diligence file that treats FDA’s own database as the record of who currently holds a given K-number is trusting a lookup that was never built to answer that question. This is regulatory intelligence about how the mechanism works, never regulatory advice on a specific transaction — whether a given deal needs more than a listing update is a call for the counsel structuring it.