FDA 510(K) Clearance
FDA 510(k) Clearance is a regulatory process established by the U.S. Food and Drug Administration (FDA) that allows medical device manufacturers to market their products in the U.S. by demonstrating that a new or modified device is "substantially equivalent" to a legally marketed device, known as a "predicate device." This process is outlined in section 510(k) of the Food, Drug, and Cosmetic Act.