510(k) Clearance

510(k) clearance is a regulatory process by the U.S. Food and Drug Administration (FDA) that allows medical devices to be marketed legally. Companies must demonstrate that their device is substantially equivalent to an already approved device (called a predicate). This process ensures safety and effectiveness without requiring full clinical trials. Once approved, the device can be sold in the U.S. market. 510(k) clearance is common for many medical tools and devices, facilitating innovation while maintaining safety standards.