FDA 510(k) anesthesiology devices include equipment used for airway management, ventilation and patient monitoring during surgical procedures. The FDA review panel code is AN.
Common device types in this category:
Data sourced from the FDA 510(k) public files. Updated monthly.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 216d |
| All-time average (cleared) | 140d |
| Not Substantially Equivalent (denied) | 492d |
Recent Anesthesiology submissions have taken longer than the historical average - 216 days in the last 2 years vs 140 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 492 days before receiving a Not Substantially Equivalent determination.
This page lists all 9002 medical devices in the Anesthesiology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Ventilators, anesthesia machines, breathing circuits and airway management devices.
This page lists 9002 medical devices in the Anesthesiology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 8984 were cleared as substantially equivalent to a predicate device. Average FDA review time: 140 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.
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