Medical DevicesLast reviewed April 2026

Traditional 510(k)(Traditional 510(k))

The standard 510(k) premarket notification pathway for Class II devices demonstrating substantial equivalence to a predicate.

Usage Examples

The Traditional 510(k) for the new device included a full substantial equivalence comparison across three predicates.
FDA cleared the Traditional 510(k) after 4 months of review including one Additional Information request.

What is Traditional 510(k)?

A Traditional 510(k) is the default 510(k) submission type for new devices, modified devices, or devices from a different applicant than the predicate. It must include full information demonstrating substantial equivalence: device description, intended use, indications for use, technological characteristics comparison, performance testing, labeling, and 510(k) summary. FDA review targets 90 days (statutory) with actual review typically 3-6 months including RTA and AI request cycles.

Traditional 510(k) is used when the device has no prior 510(k) or is from a new applicant. Modifications to own cleared devices typically use Special 510(k). Devices with well-established performance benchmarks under guidance documents can use Abbreviated 510(k). Selecting the correct 510(k) type up front avoids RTA delays and unnecessary content rework.

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 Traditional 510(k) for the new device included a full substantial equivalence comparison across three predicates.
FDA cleared the Traditional 510(k) after 4 months of review including one Additional Information request.

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

Traditional: new device, different applicant than predicate, significant technological changes. Special: modification to own cleared device without substantive change in intended use. Abbreviated: device relying on guidance document, recognized consensus standard, or special control.

FDA statutory target is 90 FDA days (not elapsed days). Actual elapsed time is typically 3-6 months including acceptance review, substantive review, and Additional Information request cycles. Complex devices or those triggering multiple AI rounds can take 9+ months.

Yes. Since October 1, 2023, all 510(k) submissions including Traditional must use the FDA eSTAR template. Paper and non-eSTAR electronic submissions are no longer accepted.