CBP · Class II · 21 CFR 868.5870

FDA Product Code CBP: Valve, Non-rebreathing

Leading manufacturers include Instrumentation Industries, Inc., Plasco, Inc. and Mem Medical, Inc..

103
Total
103
Cleared
161d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 168d avg (recent)

FDA 510(k) Cleared Valve, Non-rebreathing Devices (Product Code CBP)

103 devices
1–24 of 103
Cleared Oct 29, 2024
QualityFlow O2 Series (QualityFLOW O2)
K241366
Dehas Medical Systems GmbH
Anesthesiology · 168d
Cleared Aug 09, 2024
F&P Optiflow Flow Diverter
K234053
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Dec 23, 2021
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992
Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology · 265d
Cleared Nov 25, 2020
CPR Face Shield
K192285
Firstar Healthcare Company Limited (Guangzhou)
Anesthesiology · 461d
Cleared Apr 05, 2019
OJR215 Pressure Relief Manifold
K173770
Fisher & Paykel Healthcare Limited
Anesthesiology · 480d
Cleared Nov 17, 2017
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
K171961
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology · 140d
Cleared Jun 03, 2016
Seal Rite Non-Rebreathing Valve
K152521
The Lifeguard Store, Inc.
Anesthesiology · 274d
Cleared Jul 09, 2015
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
K142764
Hangzhou Jinlin Medical Appliances Co., Ltd.
Anesthesiology · 287d
Cleared Mar 23, 2015
BigEasy Non-Rebreathing Valve
K142402
12th Man Technologies, Inc.
Anesthesiology · 208d
Cleared Jun 04, 2014
EXHALATION VALVE
K132143
Intersurgical Incorporated
Anesthesiology · 328d
Cleared Dec 01, 2011
GENUINE FIRST AID CPR MASK
K112126
Genuine First Aid, LLC
Anesthesiology · 129d
Cleared Jul 28, 2011
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
K111191
Wet Nose Technologies, LLC
Anesthesiology · 91d
Cleared Jul 22, 2010
CPR MASK
K083418
Firstar Healthcare Co., Ltd.
Anesthesiology · 611d
Cleared Mar 25, 2010
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60
K091538
Wet Nose Technologies, LLC
Anesthesiology · 303d
Cleared Mar 13, 2009
OXYGEN DEMAND VALVE
K082345
Bpr Medical, Ltd.
Anesthesiology · 210d
Cleared Aug 26, 2008
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
K081516
Medsource International, LLC
Anesthesiology · 88d
Cleared Jul 07, 2006
LIV MEDICA CPR FACE MASK
K052458
Liv Medica Products Pvt. , Ltd.
Anesthesiology · 303d
Cleared Dec 22, 2005
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K052743
Dynarex Corp.
Anesthesiology · 83d
Cleared Mar 18, 2005
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
K042727
Foremount Ent. Co., Ltd.
Anesthesiology · 168d
Cleared Mar 04, 2004
PRESSURE MANIFOLD, MODEL BC 110
K040366
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 20d
Cleared Apr 22, 2003
MODIFICATION TO HIOX
K030943
Sensor Medics Corp.
Anesthesiology · 27d
Cleared Jul 30, 2002
HI-OX
K020665
Sensor Medics Corp.
Anesthesiology · 151d
Cleared May 31, 2000
RUSCH EMERGENCY MASK
K993528
Rusch, Inc.
Anesthesiology · 226d
Cleared Nov 03, 1999
FACE-2-FACE CPR PROTECTION SHIELD
K991617
Whiteline Plastics, Inc.
Anesthesiology · 177d

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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - CBP Product Code

FDA review times for CBP submissions have been consistent, averaging 168 days recently vs 161 days historically.

CBP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →