Medical DevicesLast reviewed April 2026

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

How to File a 510(k) Premarket Notification with FDA

Submit a 510(k) to obtain FDA clearance for a Class II medical device based on substantial equivalence to a predicate.

1
Confirm 510(k) is the right pathway
Verify device classification via Product Classification Database. Class III requires PMA; no predicate typically requires De Novo. Exempt Class I/II devices don't need 510(k). Choose Traditional, Abbreviated, or Special 510(k) based on applicability.
2
Select a legally marketed predicate
Search the 510(k) database for predicates with matching intended use and compatible technological characteristics. Multi-predicate strategies permitted; avoid split predicate patterns that trigger FDA questions.
3
Conduct performance testing
Bench testing per recognized consensus standards (ISO 10993 biocompatibility, IEC 62304 software, IEC 60601 electrical safety, device-specific standards). Clinical data only if required by special controls or novel characteristics.
4
Prepare eSTAR package
Populate FDA eSTAR interactive PDF template with device description, predicate comparison, performance testing summaries, labeling, and administrative content. eSTAR's built-in validation catches structural gaps.
5
Submit via CDRH Portal
Upload the eSTAR package to FDA CDRH Portal. Pay MDUFA user fee. Receive submission tracking number.
6
Pass 15-day acceptance review
FDA conducts acceptance review over 15 calendar days. Responds with "accepted" or "Refuse to Accept" (RTA). RTA requires remediation and resubmission; clock restarts.
7
Support substantive review
Respond to Additional Information (AI) requests within allotted time. Typical clearance time 3-6 months from acceptance including AI cycles. Special 510(k) target is 30 days; Abbreviated slightly faster than Traditional.
8
Receive clearance letter
FDA issues clearance letter establishing the K-number. Device can be marketed in labeled configuration. Maintain cleared device lifecycle via Special 510(k) for modifications by same applicant.

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.