What is FDA 510k?

The 510(k) is a premarket submission to the FDA for a medical device that demonstrates the device is substantially equivalent to a legally marketed device already approved by the FDA. The name "510(k)" comes from the section of the Federal Food, Drug, and Cosmetic Act that governs the process. The purpose of the 510(k) submission is to inform the FDA that a device meets the regulatory standards, thereby demonstrating its safety and effectiveness.
Devices that require a FDA 510k submission typically fall into Class II. Class II devices are considered to pose moderate risks to patients compared to Class I (low-risk) or Class III (high-risk) devices, which require more stringent approvals like Premarket Approval (PMA).