FDA 510(k) Pathology Devices
About Pathology Devices
FDA 510(k) pathology devices include instruments used in anatomical and clinical pathology laboratories. The FDA review panel code is PA.
Key categories:
- Tissue staining systems - automated H&E, IHC and special stain platforms
- Histology instruments - microtomes, tissue processors and embedding stations
- Digital pathology - whole slide imaging (WSI) scanners and image analysis software
- Cytology systems - liquid-based cytology and automated cell screening
Most pathology devices are Class I or Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Pathology Devices
This page lists all 18 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.
- 14 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 220 days.
- Records available from 2015 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 18 medical devices in the Pathology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 14 were cleared as substantially equivalent to a predicate device. Average FDA review time: 220 days. Records from 2015 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to pathology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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.