Can other companies use one company's 510(k) to market their own device?

For a question from one of my clients

Ans:  The company that owns the 510(k) is the only one to use that 510(k) to market the device in the US.  It is also the only one who can make regulatory decisions about that device and its 510(k) content, e.g., device changes and when its necessary to submit a new 510(k).  The submitting company (unless the 510(k) was sold along with the device to another company), is the one solely responsible for its content and "updates" / submissions to the FDA, and the FDA checks for this during each inspection; if the last inspection had no problems with the product / its 510(k), it's safe to say that the device / 510(k) has no problems (unless new data received by the company, e.g., complaints, test data, or similar) say otherwise.  

Is another company (other than distributers) trying to use the device owner company's 510(k) to sell products to other companies? If so, that would not be permissible.  Each company ordering that type of device for themselves for resale under their own name has to have their own 510(k), or, in the case of a procedure tray/kit, have a 510(k)  themselves for the kit, and per the 510(k) for kits from the FDA, maintain a file for every class 2 device in the kit, each having it's own 510(k) or one covered by the kit's 510(k),  providing the device hasn't been modified, retains its original labeling / primary packaging;  Sterilization / re-sterilization may be allowed if test data shows no device degradation and maintains its proper function and sterility (part of the data submitted to the FDA for review of the kit 510(k)).  

Further, companies manufacturing devices for sale to other companies cannot use someone else's 510(k) for their customer's use (they or their customer has to have at least one applicable 510(k) for that device in order to market it).

- jel@jelincoln.com