FDA Clearance (510(k))
Also known as: 510(k)
The most common FDA regulatory pathway used to authorize marketing of moderate-risk medical devices, including many AI diagnostic tools, in the U.S.
FDA 510(k) clearance is the most common regulatory pathway the U.S. Food and Drug Administration uses to authorize marketing of moderate-risk medical devices, including many AI-based diagnostic and imaging tools. A 510(k) clearance requires the manufacturer to demonstrate the device is substantially equivalent to an already-legally-marketed device.
510(k) clearance is not the same as FDA "approval," which is a separate, generally more rigorous pathway used for higher-risk devices and most drugs. Marketing language sometimes blurs this distinction, so the specific regulatory pathway is worth checking directly for any clinical AI product.