FDA 510(k) Glossary · submission

Abbreviated 510(k)

An Abbreviated 510(k) is a 510(k) submission format that relies on a manufacturer's conformance with FDA-recognized standards, special controls guidance documents, or FDA guidance to demonstrate substantial equivalence. It streamlines the submission by substituting standard conformance for detailed comparative testing data.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
Abbreviated 510(k) submissions appear throughout the dataset. The format is commonly used in device categories with FDA-recognized performance standards such as cardiovascular and radiology.

Definition

An Abbreviated 510(k) is a premarket notification format that relies on conformance with FDA-recognized standards, special controls guidance, or FDA guidance documents to streamline the demonstration of substantial equivalence. It was introduced by the FDA as part of the New 510(k) Paradigm to reduce submission burden where recognized standards exist.

When to Use Abbreviated 510(k)

The Abbreviated format is appropriate when:

  • The FDA has recognized a performance standard applicable to the device type.
  • The FDA has issued special controls guidance that addresses the device's safety and effectiveness.
  • The manufacturer's device fully conforms to the applicable standard(s).

Comparison of 510(k) Types

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

FDA References

Related Terms

Traditional 510(k) - Special 510(k) - Special Controls - 510(k) Premarket Notification

Frequently Asked Questions

An Abbreviated 510(k) is a submission format that uses conformance with FDA-recognized standards or guidance documents as the primary basis for demonstrating substantial equivalence. Instead of providing extensive comparative test data, the manufacturer declares conformance with relevant recognized standards (e.g., ISO, IEC, ASTM) and includes a summary of testing. This simplifies the submission when applicable standards exist.

An Abbreviated 510(k) is appropriate when FDA-recognized performance standards, special controls guidance, or FDA guidance documents exist for the device type and the manufacturer's device conforms to those standards. The manufacturer must identify the applicable recognized standards and submit a declaration of conformity, supported by test summaries.

A Traditional 510(k) requires a full comparative analysis between the new device and the predicate. An Abbreviated 510(k) replaces some or all of that comparative data with declarations of conformance to recognized standards. The Abbreviated format can be faster to prepare when applicable standards exist, as manufacturers substitute standard test reports for custom comparative studies.