A 510(k) is a premarket notification submitted to the United States Food and Drug Administration to demonstrate that a device is substantially equivalent to a legally marketed device, known as a predicate, that is not subject to premarket approval. The name comes from section 510(k) of the Federal Food, Drug, and Cosmetic Act.
It is the most common route to the US market and applies to the majority of Class II devices. If the FDA agrees that substantial equivalence has been demonstrated, it issues a clearance letter and the device may be marketed.
The distinction is legally and commercially important. Clearance means the device is comparable to something already on the market. Premarket approval (PMA), the pathway for Class III devices, is a far more demanding process requiring valid scientific evidence, usually including clinical trials, that the device is safe and effective in its own right. Describing a 510(k) device as FDA approved is inaccurate and is a recurring compliance issue in marketing material.
The De Novo pathway provides a route for novel low to moderate risk devices with no suitable predicate, creating a new classification that later devices can use as a predicate themselves. Some device types are exempt from 510(k) altogether. Special and abbreviated 510(k) options exist for modifications to a manufacturer's own cleared device and for submissions relying on recognised standards or guidance.
Manufacturers planning both markets should not assume the work transfers directly. The FDA reviews the submission itself, whereas in the EU a Notified Body assesses conformity. Evidence expectations, classification rules and terminology differ, and the MDR's restriction of equivalence claims means a US predicate argument rarely satisfies a European clinical evaluation.
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