FDA 510(k) submission

A FDA 510(k) submission is a regulatory process where medical device manufacturers demonstrate that their device is substantially equivalent to an existing legally marketed device, called a predicate. This allows the manufacturer to gain FDA clearance to market the device in the U.S. without going through full premarket approval. The submission includes technical details, testing data, and information showing safety and effectiveness. The goal is to ensure that new medical devices meet quality standards and pose no greater risk to patients than existing devices.