Glossary
510(k)
The FDA's most common route for medical devices, which clears a device shown to be substantially equivalent to one already on the market.
A 510(k), named for a section of the US Food, Drug, and Cosmetic Act, is a premarket notification to the Food and Drug Administration. The maker shows that its device is "substantially equivalent" in intended use and safety and effectiveness to a legally marketed device, called a predicate. If the FDA agrees, it clears the device.
Most AI-enabled medical devices in the United States have reached the market through this pathway.
"FDA-cleared" is not the same as "FDA-approved," a term reserved for the stricter premarket approval process used for higher-risk devices. Clearance also does not mean the device has been shown to improve patient outcomes.
Read more: our explainer