FDA 510(k) Anesthesiology Devices
About Anesthesiology Devices
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:
- Ventilators and breathing circuits - Class II devices requiring special controls
- Anesthesia delivery systems - gas machines, vaporizers and infusion pumps
- Airway management devices - laryngoscopes, endotracheal tubes, masks
- Patient monitoring systems - SpO2, capnography and gas analyzers
Data sourced from the FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Anesthesiology Devices
This page lists all 8948 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.
- 8931 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 139 days.
- Records available from 1976 to the present.
- Filter by product code using the sidebar to narrow results by device type.
Using this Anesthesiology 510(k) Regulatory Dataset
This page lists 8948 medical devices in the Anesthesiology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 8931 were cleared as substantially equivalent to a predicate device. Average FDA review time: 139 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 anesthesiology
- 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 anesthesiology device? Search by device name, K-number or manufacturer.
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