FDA 510(k) pathology devices include instruments used in anatomical and clinical pathology laboratories. The FDA review panel code is PA.
Key categories:
Most pathology devices are Class I or Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 212d |
| All-time average (cleared) | 76d |
| Not Substantially Equivalent (denied) | 192d |
Recent Pathology submissions have taken longer than the historical average - 212 days in the last 2 years vs 76 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 192 days before receiving a Not Substantially Equivalent determination.
This page lists all 1101 medical devices in the Pathology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Tissue staining, automated histology and anatomical pathology instruments.
This page lists 1101 medical devices in the Pathology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 1078 were cleared as substantially equivalent to a predicate device. Average FDA review time: 76 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
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