FDA 510(k) General Hospital Devices
About General Hospital Devices
FDA 510(k) general hospital devices cover a broad range of equipment used across hospital departments. The FDA review panel code is HO.
This is one of the largest 510(k) categories, with 17,707 submissions since 1976. It includes:
- Infusion and delivery systems - IV pumps, syringe drivers, enteral feeding
- Vascular access devices - IV catheters, PICC lines, ports
- Hospital beds and patient handling - adjustable beds, transfer devices
- Sterilization and disinfection - autoclaves, chemical disinfectants, endoscope reprocessors
- Wound care - negative pressure wound therapy, dressings
FDA 510(k) Cleared General Hospital Devices
This page lists all 339 medical devices in the General Hospital specialty that have been submitted to the FDA through the 510(k) premarket notification process. Infusion pumps, IV sets, syringes and general-purpose hospital equipment.
- 337 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 169 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 339 medical devices in the General Hospital specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 337 were cleared as substantially equivalent to a predicate device. Average FDA review time: 169 days. Records from 2021 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 general hospital
- 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 general hospital device? Search by device name, K-number or manufacturer.
Search all General Hospital 510(k) devices