FDA Product Code CBP: Valve, Non-rebreathing
Leading manufacturers include Respironics, Inc., Fisher & Paykel Healthcare Limited and Firstar Healthcare Company Limited (Guangzhou).
103
Total
103
Cleared
161d
Avg days
1977
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
200d
recently vs 160d historically
FDA 510(k) Cleared Valve, Non-rebreathing Devices (Product Code CBP)
103 devices
Cleared
Oct 29, 2024
QualityFlow O2 Series (QualityFLOW O2)
Dehas Medical Systems GmbH
Anesthesiology
168d
Cleared
Aug 09, 2024
F&P Optiflow Flow Diverter
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
231d
Cleared
Dec 23, 2021
Altech® Exhalation Valve (Single Limb and Dual Limb)
Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology
265d
Cleared
Nov 25, 2020
CPR Face Shield
Firstar Healthcare Company Limited (Guangzhou)
Anesthesiology
461d
Cleared
Apr 05, 2019
OJR215 Pressure Relief Manifold
Fisher & Paykel Healthcare Limited
Anesthesiology
480d
Cleared
Dec 08, 1983
RESCUE VALVE
Respironics, Inc.
Anesthesiology
43d
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 510(k) Review Time - CBP Product Code
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 →