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:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 158d |
| All-time average (cleared) | 128d |
| Not Substantially Equivalent (denied) | 468d |
Recent General Hospital submissions have taken longer than the historical average - 158 days in the last 2 years vs 128 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 468 days before receiving a Not Substantially Equivalent determination.
This page lists all 17754 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.
This page lists 17754 medical devices in the General Hospital specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 17729 were cleared as substantially equivalent to a predicate device. Average FDA review time: 128 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.
Looking for a specific general hospital device? Search by device name, K-number or manufacturer.
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