510(k) Premarket Notification
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A 510(k) is a premarket submission demonstrating that a new device is at least as safe and effective as — substantially equivalent to — a legally marketed predicate device, allowing it to reach the US market without the more extensive clinical evidence a PMA requires. It is the pathway used for the large majority of moderate-risk, Class II devices.
The submission compares the new device’s intended use and technological characteristics to a predicate already on the market, supported by performance testing sufficient to show that any differences do not raise new questions of safety or effectiveness. FDA’s standard review goal is 90 days from acceptance, though the clock stops for FDA requests for additional information.
Where no suitable predicate exists, or where the predicate itself is under question, a novel low-to-moderate-risk device may instead qualify for the De Novo pathway rather than 510(k). A cleared 510(k) device can itself become a predicate for future submissions, which is how device families evolve incrementally over successive clearances.
- —Demonstrates substantial equivalence to a legally marketed predicate device
- —Used for the large majority of Class II (moderate-risk) devices
- —Standard FDA review goal is 90 days from acceptance
- —A cleared 510(k) device can serve as the predicate for a later submission
- —Devices without a suitable predicate may instead route through De Novo classification
FD&C Act §510(k); 21 CFR Part 807 Subpart E
Frequently asked questions
What is 510(k) Premarket Notification?
A 510(k) is a premarket submission demonstrating that a new device is at least as safe and effective as — substantially equivalent to — a legally marketed predicate device, allowing it to reach the US market without the more extensive clinical evidence a PMA requires. It is the pathway used for the large majority of moderate-risk, Class II devices.
Which regulations cover 510(k) Premarket Notification?
FD&C Act §510(k); 21 CFR Part 807 Subpart E