FDA 510k submission is also known as a pre-market notification. This includes technical, performance, and safety information about the medical device. A submission must be made for devices that do not need a premarket approval (PMA) and are not exempt from the requirements by manufacturers who wish to market their medium-risk medical device, or IVD, in the U.S.
A 510k is the technical dossier that must be submitted to the US Food and Drug Administration for devices meant to be used on humans. The application is made to the FDA by a medical device manufacturer or a specification developer to demonstrate that the device to be marketed is as safe and effective, or substantially equivalent, to a legally marketed device in the USA.
The 510k documentation must include a description of the medical device, models, and accessories or components that come into direct contact with patients, as well as device performance specifications. Once the FDA determines the submitted device is substantially equivalent, a 510k number is granted, or, in other words, 510k approval is granted.