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 510 approval FDA?
A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. Learn more...What is a 510k clearance?
510(k) Clearance. The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976).