An FDA 510k is the technical dossier that must be submitted to the US Food and Drug Administration (FDA) 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, substantially equivalent, to a legally marketed device in the USA.
The 510(k) documentation must include a description of the medical device, models, and accessories or components that come in direct contact with patients, as well as device performance specifications. Once FDA determines the submitted device is substantially equivalent, a 510(k) number is granted, or in other words, 510k approval is granted. It is not to be called an FDA 510k Certification.