Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices. A 510(k) is also required for manufacturers changing the intended use of their device, or changing the technology of a cleared device in such a way that it may significantly affect the device’s safety or effectiveness. To be cleared for sale by the FDA under 510(k) scheme, the first step is to identify predicate device(s), which is a medical device already approved by the FDA and is substantially similar to the one for which FDA approval is being sought.