FDA 510(k) Glossary · submission

Special 510(k)

A Special 510(k) is a streamlined 510(k) submission format used when a manufacturer modifies their own previously cleared device. It relies on the manufacturer's design controls and risk analysis rather than a new substantial equivalence comparison, and is typically reviewed faster than a Traditional 510(k).
Dataset Insight - 510k Database (166,200 records, 1980–2025)
Special 510(k) submissions appear throughout the dataset. K-numbers from Special submissions follow the same format as Traditional submissions and are not separately flagged in the public dataset.

Definition

A Special 510(k) is a streamlined premarket notification format introduced by the FDA in 1998 to expedite review of modifications to previously cleared devices. It is available only to the original manufacturer of the cleared device and applies when the modification does not affect the intended use or alter the fundamental scientific technology of the device.

Requirements for a Special 510(k)

  • The submitter must be the same manufacturer whose device was previously cleared.
  • The modification must not change the intended use of the device.
  • The modification must not alter the fundamental scientific technology.
  • The manufacturer must have an established design control system in place.

Review Timeline

The FDA targets a 30-day review for Special 510(k)s, compared to the 90-day target for Traditional 510(k)s. This makes it a significant strategic advantage for manufacturers who need to iterate quickly on cleared devices.

Comparison of 510(k) Types

See Traditional 510(k) for a full comparison table of all three submission types.

FDA References

Related Terms

Traditional 510(k) - Abbreviated 510(k) - 510(k) Premarket Notification - PCCP

Frequently Asked Questions

A Special 510(k) is a streamlined submission format for manufacturers modifying their own previously cleared device. Instead of a full substantial equivalence comparison to a predicate, the Special 510(k) relies on the manufacturer's design controls and risk analysis demonstrating that the modification does not alter the device's intended use or fundamental scientific technology.

A Special 510(k) can be used when: the modification is to a device the manufacturer itself previously had cleared; the modification does not affect the intended use of the device; and the modification does not alter the fundamental scientific technology. Examples include software updates, manufacturing changes, or materials changes that maintain device performance.

Yes, typically. The FDA aims to review Special 510(k)s within 30 days (vs 90 days for Traditional). The streamlined format - relying on design controls rather than a new predicate comparison - reduces review complexity. Not all Special 510(k)s are reviewed within 30 days, but they generally achieve shorter total review times in practice.