Traditional · Abbreviated · Special 510(k)
The three-track 510(k) system — Traditional, Abbreviated, and Special — is a US-specific structure. The Abbreviated route uses FDA-recognised consensus standards to reduce the data burden.
There are three types of 510(k) submissions, each appropriate for different circumstances.
Traditional 510(k)
The Traditional 510(k) is the standard submission format. It includes all information necessary to demonstrate substantial equivalence, including:
- Device description and intended use
- Comparison to predicate (intended use and technological characteristics)
- Performance testing data
- Labelling
- Any required clinical data
- 510(k) summary or statement
When to use: For new devices without a declared conformity to relevant FDA-recognised standards, or where the Abbreviated or Special pathways are not applicable.
Abbreviated 510(k)
The Abbreviated 510(k) relies on FDA-recognised consensus standards (e.g., ISO standards, ASTM standards) or FDA guidance documents to demonstrate aspects of safety and effectiveness. Rather than providing the full underlying test data, the submitter provides:
- A declaration of conformity to the recognised standard(s)
- A summary report describing:
- Which standards were used
- The tests performed
- The results (pass/fail)
- Attestation that full test records are available for FDA inspection
When to use: When relevant FDA-recognised standards exist for your device type. The FDA-recognised standards list is searchable at accessdata.fda.gov.
Advantage: Can significantly reduce submission size and review time.
Special 510(k)
The Special 510(k) is for modifications to your own legally marketed device (i.e., modifications to a 510(k)-cleared device you hold). It is not for marketing a new device — it is for changes to an existing device.
Eligibility: The modification:
- Is a change to a legally marketed device (your own 510(k) or PMA)
- Can be evaluated using well-established methods
- Does not raise complex questions of safety and effectiveness
Key features:
- Streamlined review target: 30 calendar days
- Relies on your device design control records (design history file)
- Summary report format — does not require full performance data submission
- A Declaration of Conformity to relevant recognised standards
When to use: For design changes, material changes, software updates, or labelling revisions that fall below the PMA supplement threshold but require a new 510(k).
Choosing the right type
| Situation | Recommended type |
|---|---|
| New device, comprehensive data package | Traditional |
| New device, relevant ISO/ASTM standards available | Abbreviated |
| Change to your own cleared device | Special |
| Change is major / raises new SE questions | Traditional with new predicate |