510(k) holder

The holder is not always the company that makes or sells the device, because clearances can be transferred or acquired. When a change is planned, the holder is the one who decides whether a new 510(k) is needed and who submits it.

The person who possesses the 510(k) clearance for a device.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology