A 510k is a premarket submission required for certain medical devices under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. The purpose of this submission is to demonstrate that the device in question is “substantially equivalent” to an already FDA-cleared device, known as a predicate device.

Devices cleared through the 510(k) process can then be marketed in the U.S. without undergoing a more extensive Premarket Approval (PMA) process, which is typically reserved for high-risk devices.