510(k) Premarket Notification

What is a 510(k) premarket notification?

A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is at least as safe and effective — substantially equivalent — as a legally marketed predicate device. A successful review ends in an FDA order finding the device substantially equivalent, commonly called clearance. Clearance is not approval: the FDA is not independently concluding that the device is safe and effective, but that it is equivalent to a device already on the market.

Which devices need a 510(k)?

Most Class II devices, plus the minority of Class I devices that are not 510(k)-exempt. Class III devices generally require premarket approval instead, and novel devices without a predicate may use the De Novo pathway. Classification — and therefore the correct pathway — is looked up by FDA product code and the device classification regulation, which is where U.S. planning starts.

How long does 510(k) review take?

The MDUFA performance goal for a Traditional 510(k) decision is 90 FDA days, but the clock stops when the agency issues an Additional Information request, so real calendar time depends heavily on submission quality. Submissions are filed electronically in eSTAR format, and a Refuse-to-Accept screening precedes substantive review.

How do I search the FDA 510(k) database?

Every clearance is public. The FDA's 510(k) database is searchable by device name, applicant, product code and clearance number, and it is the standard tool for identifying candidate predicates and studying how similar devices were described and tested.

Does a 510(k) expire?

No — a clearance has no expiry, but it covers the device as cleared. Significant changes to intended use or technology can require a new 510(k), which is a core change-control judgment for cleared manufacturers. A cleared device still requires establishment registration and device listing, and quality-system compliance under the QMSR.