510(k) Clearance
Also called: premarket notification, 510k
The most common FDA route to market, based on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical benefit.
A 510(k) submission argues that a new device is substantially equivalent to an existing legally marketed one in intended use and technological characteristics. If the FDA agrees, the device is cleared. The great majority of authorized AI medical devices came through this route.
Clearance is not approval, and the distinction is substantive. The agency has not independently validated clinical performance, and the manufacturer has not been required to demonstrate the device is better than anything.
Where This Gets Misread
Because each clearance can cite a previously cleared device as its predicate, capability can drift across a chain of submissions without any single step requiring new clinical evidence. Reading "FDA cleared" as "FDA tested and endorsed" is the single most common misreading in this entire field.