FDA Product Code CAH: Filter, Bacterial, Breathing-circuit
Leading manufacturers include Ambu A/S, Ningbo Huakun Medical Equipment Co., Ltd. and Shaoxing Haitech Medical Products Co., Ltd..
FDA 510(k) Cleared Filter, Bacterial, Breathing-circuit Devices (Product Code CAH)
About Product Code CAH - Regulatory Context
510(k) Submission Activity
201 total 510(k) submissions under product code CAH since 1976, with 201 receiving FDA clearance (average review time: 127 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under CAH have taken an average of 264 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.
CAH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →