In which situation would a device NOT require a 510(k) submission?

A device does not require a 510(k) submission when it is a new type that has no predicate because the 510(k) pathway is designed for devices that are demonstrated to be substantially equivalent to an existing device on the market. A new type typically means there are no comparable devices to which it can be compared, making the notion of "substantial equivalence" inapplicable. In such cases, the manufacturer may need to pursue the Premarket Approval (PMA) pathway or explore other regulatory options, as 510(k) submissions are specifically for devices that can reference existing products.

The other choices relate to scenarios where a 510(k) submission would generally still be necessary. Devices that are deemed substantially equivalent to existing devices or have been modified to improve safety often require a 510(k) to establish that safety and effectiveness align with regulatory standards. Furthermore, devices sold solely in international markets may not fall under the 510(k) requirement, but any intent to market in the United States would necessitate compliance with FDA regulations, including a 510(k) submission if it aims to operate within that specific market.