510(k) Pathology Devices

FDA 510(k) Cleared Pathology Devices

This page lists all 1099 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.

• 1076 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 76 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.