The reprocessor holds the 510(k)

A device-portfolio team that only watches its own firm name in FDA’s registration and listing records can go years without learning that a used copy of its device is back on the market — cleaned, resterilized, and resold under someone else’s name. That is not a gap in the record. It is the record working exactly as FDA built it: since 2000, the reprocessor has been the manufacturer.

One guidance, one reclassification

FDA’s August 2000 guidance, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, set the policy that still governs the field: a third-party or hospital reprocessor that cleans, sterilizes, and resells a device labeled for single use is not servicing someone else’s product. It is manufacturing a device of its own, subject to the same statutory requirements — registration, listing, premarket submission, adverse event reporting, labeling — as the firm that built the device the first time.

Its own 510(k), not a repair record

For most Class II single-use devices, that means the reprocessor files and holds its own 510(k), demonstrating the reprocessed device remains substantially equivalent to a predicate — typically the original, unreprocessed device — after cleaning, sterilization, and however many cycles the reprocessor claims it can withstand. The Medical Device User Fee and Modernization Act of 2002 went further for devices FDA judged critical or semicritical: firms reprocessing those had to submit cleaning, sterilization, and functional-performance validation data in the 510(k) itself, and FDA terminated the premarket-notification exemptions some had relied on, publishing the affected device list in 2003.

The reprocessed device answers to a predicate. The 510(k) that clears it answers to a different firm.

Same product code, different name on the file

None of this changes what the device is. A reprocessed unit keeps the same intended use, and typically the same product code and regulation number, as the device it once was — which is exactly why a reprocessor’s 510(k) can, and usually does, cite the original firm’s device as its predicate. What changes is who FDA considers responsible for it: registration, listing, the 510(k) holder of record, and the adverse event reports all run under the reprocessor’s name, not the original manufacturer’s.

The practice

A watch keyed only to a firm name will never surface this, because the reprocessed device was never registered or listed under that firm to begin with. A watch keyed to product code or regulation number can, because the reprocessed device was classified into the same category its original occupies. Reading that record correctly means recognizing a K-number filed under an unfamiliar firm, citing your device as predicate, for what it is — a reprocessor’s own submission, not a competitor’s redesign of your product. That reading is regulatory intelligence and method, never regulatory advice about a specific device or firm — the determination belongs with your regulatory team.