FDA 510(k) Hematology Devices
About Hematology Devices
FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.
Key device categories:
- Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
- Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
- Flow cytometry systems - immunophenotyping and cell sorting
- Blood typing and cross-match systems - transfusion medicine instruments
Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Hematology Devices
This page lists all 3291 medical devices in the Hematology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Blood analyzers, cell counters and coagulation diagnostic systems.
- 3284 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 113 days.
- Records available from 1976 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 3291 medical devices in the Hematology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 3284 were cleared as substantially equivalent to a predicate device. Average FDA review time: 113 days. Records from 1976 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 hematology
- 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.
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices