FDA Product Code CBP: Valve, Non-rebreathing
Leading manufacturers include Fisher &Paykel Healthcare , Ltd. and Dehas Medical Systems GmbH.
FDA 510(k) Cleared Valve, Non-rebreathing Devices (Product Code CBP)
About Product Code CBP - Regulatory Context
510(k) Submission Activity
103 total 510(k) submissions under product code CBP since 1977, with 103 receiving FDA clearance (average review time: 161 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under CBP have taken an average of 200 days to reach a decision - up from 160 days historically. Manufacturers should account for longer review timelines in current project planning.
CBP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →