Medical Devices

510(k) Premarket Notification(510(k))

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

Usage Examples

The 510(k) cited three predicates to establish substantial equivalence.
FDA cleared the 510(k) after a 90-day review.
The company filed a Special 510(k) for the design modification.

What is 510(k)?

A 510(k) premarket notification is a regulatory submission to FDA demonstrating that a new medical device is "substantially equivalent" to a legally marketed predicate device. Substantial equivalence means the device has the same intended use and either the same technological characteristics, or different characteristics that do not raise new safety or effectiveness questions.

The 510(k) pathway is the most common route to market for Class II medical devices and some Class I devices. FDA review typically takes 3-6 months. A cleared 510(k) allows the device to be marketed but does not constitute FDA approval.

Types include Traditional 510(k), Abbreviated 510(k) (using guidance documents or special controls), and Special 510(k) (for modifications to own cleared devices).

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 807, FDCA SECTION 510K.

FDA CDRHEMAHealth Canada

When This Matters

The 510(k) cited three predicates to establish substantial equivalence.
FDA cleared the 510(k) after a 90-day review.
The company filed a Special 510(k) for the design modification.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 807FDCA SECTION 510K

Frequently Asked Questions

A predicate is a legally marketed device to which substantial equivalence is claimed. It can be a pre-1976 device (preamendments), a 510(k)-cleared device, a De Novo classified device, or a reclassified device.

510(k) demonstrates substantial equivalence to a predicate (lower burden), while PMA requires clinical evidence of safety and effectiveness (higher burden). 510(k) is for lower-risk devices; PMA is for Class III high-risk devices.

Class I devices exempt from 510(k), Class II devices exempt per regulation, modifications that don't affect safety/effectiveness, and devices legally marketed before May 28, 1976.