FDA 510(k) Glossary · submission

Traditional 510(k)

A Traditional 510(k) is the standard format for a 510(k) premarket notification submission, used when a manufacturer is introducing a new device and must demonstrate substantial equivalence to a legally marketed predicate. It is the most commonly used of the three 510(k) submission types.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
Traditional 510(k) is the most common submission type in the 166,200-record dataset. Submission type is not separately tracked; most non-Special submissions are Traditional format.

Definition

A Traditional 510(k) is the standard premarket notification format under Section 510(k) of the FD&C Act. It is used when a manufacturer introduces a new device to the U.S. market and must demonstrate substantial equivalence to a legally marketed predicate device through a comprehensive comparative analysis.

The Three 510(k) Submission Types

TypeWhen to UseKey Characteristic
Traditional New device, no applicable standard or guidance Full comparative analysis with predicate
Abbreviated Device meets FDA-recognized standard or guidance Relies on conformance to recognized standards
Special Modification to manufacturer's own cleared device Design controls and risk analysis for the change

Key Components of a Traditional 510(k)

  • Device description and intended use
  • Predicate device identification and comparison
  • Performance data and testing results
  • 510(k) summary or statement
  • Truthful and accurate statement
  • Class II special controls compliance
  • Labeling samples

FDA References

Related Terms

Abbreviated 510(k) - Special 510(k) - 510(k) Premarket Notification - Predicate Device

Frequently Asked Questions

A Traditional 510(k) is the standard premarket notification format used by manufacturers who are introducing a new device and need to demonstrate substantial equivalence to a predicate device. It is used when neither the Abbreviated 510(k) nor Special 510(k) formats apply. The Traditional format requires a full comparative analysis between the new device and the predicate.

A Traditional 510(k) is used when the manufacturer cannot use the Abbreviated format (no relevant FDA guidance or recognized standard applies) and is not modifying their own previously cleared device (which would use the Special format). Most first-time submissions for a new device type use the Traditional format.

The FDA accepts three 510(k) formats: (1) Traditional 510(k) - the standard format for most new device submissions; (2) Abbreviated 510(k) - for devices relying on FDA-recognized standards or special controls guidance; (3) Special 510(k) - for manufacturers modifying their own previously cleared device, when the modification does not affect the intended use or alter the fundamental scientific technology.