A 510(k) submission is a regulatory process required by the U.S. Food and Drug Administration (FDA) for certain medical devices before they can be marketed in the United States. It demonstrates that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. The submission typically includes device descriptions, labeling, performance data, and test results. Successful FDA clearance of a 510(k) allows the manufacturer to legally sell the device in the U.S. market.