FDA 510(k) Anesthesiology Devices

FDA 510(k) Anesthesiology Devices - Regulatory Overview

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.