Confusion on 510(k) Transfer Guidance - Device Listing


Hi all, :bigwave:

and there may only be one 510(k) holder for a device at a time

This statement is confusing me greatly.

We have four establishments (medical gloves) registered in the FURLS database all under the same ownership:

1. Specification Developer and Foreign Exporter
2. Contract Manufacturer 1
3. Contract Manufacturer 2
4. Contract Manufacturer 3

If the Spec Developer is the 510(k) holder, can the contract manufacturers produce under the 510(k) simultaneously?

In order to get device listings, we need to "associate" the 510(k) with the contract manufacturer - which I think makes the contract manufacturer the presumptive 510(k) holder. Would that mean we theoretically would have to activate and deactivate our device listing according to our production/shipping schedule?

Or can the Spec Developer / Foreign Exporter list the devices produced by the contract manufacturers itself?

I hope my questions make sense and thank you in advance for any answers.


Ronen E

Problem Solver

"510(k) holder" refers to proprietary ownership. In that sense there can only be one 510(k) holder (owner) at a time. Other entities can manufacture and list under the same 510(k) while not being the owner.

Both specification developers and contract manufacturers need to list (the same device).

I hope that that's clear.

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