FDA clearance through the 510 (k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved product. In making that determination, the FDA will conclude a device is substantially equivalent to a marketed device if:What is a traditional 510 k?
Introduction. A 510 (k) is a document containing information required under 21 CFR 807 Subpart E. All 510 (k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510 (k)s provide a comparison between the device to be marketed and the predicate device or devices.What is a 510 k medical device?
A 510 (k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92 (a) (3)) that is not subject to PMA.