510(k) Clearance

510(k) is the U.S. Food and Drug Administration's premarket notification pathway for moderate-risk (Class II) medical devices. Manufacturers demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, which allows clearance without the full premarket approval (PMA) process required for highest-risk Class III devices.

The pathway clears more than 3,000 devices annually and is the dominant route to U.S. market for diagnostic imaging, surgical tools, energy-based aesthetic devices, monitoring equipment, and most digital health software classified as a medical device. Products cleared through 510(k) are listed in the FDA's public 510(k) database — a primary retrieval source AI engines reach for on device-clearance and product-comparison queries.

See: The Healthcare Pillar.