CBP · Class II · 21 CFR 868.5870

FDA Product Code CBP: Valve, Non-rebreathing

Leading manufacturers include Instrumentation Industries, Inc., Hudson Oxygen Therapy Sales Co. and Fisher &Paykel Healthcare , Ltd..

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 Mar 04, 2004
PRESSURE MANIFOLD, MODEL BC 110
K040366
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 20d
Cleared Jul 01, 1999
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K983631
Instrumentation Industries, Inc.
Anesthesiology · 259d
Cleared Aug 24, 1998
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725
Instrumentation Industries, Inc.
Anesthesiology · 181d
Cleared Feb 03, 1998
NON-REBREATHING 'T' (BE 117)
K973066
Instrumentation Industries, Inc.
Anesthesiology · 169d
Cleared Sep 18, 1997
ONE-WAY VALVE (WITH CONNECTOR)
K970780
Instrumentation Industries, Inc.
Anesthesiology · 198d
Cleared Jun 10, 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634
Boston Medical Products, Inc.
Anesthesiology · 182d
Cleared Oct 07, 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 17d
Cleared May 21, 1987
CARHILL ONE-WAY RESUSCITATION VALVE
K864681
Life Design Systems, Inc.
Anesthesiology · 170d
Cleared May 04, 1987
NO. 1552, VALVED VENTI-COMP
K870895
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 60d
Cleared Mar 06, 1987
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
K870138
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 52d
Cleared Mar 06, 1987
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
K870253
Intertech Resources, Inc.
Anesthesiology · 43d
Cleared Dec 08, 1983
RESCUE VALVE
K833748
Respironics, Inc.
Anesthesiology · 43d
Cleared Sep 26, 1983
RESUSCITATION VALVE
K832868
Boehringer Laboratories
Anesthesiology · 33d
Cleared Jul 26, 1983
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K831246
Airlife, Inc.
Anesthesiology · 99d
Cleared Feb 23, 1981
CM 3
K810348
Instrumentation Industries, Inc.
Anesthesiology · 13d
Cleared May 04, 1979
NON-REBREATHING T PIECE
K790820
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 3d
Cleared Mar 12, 1979
ONE-WAY VALVE
K790151
Airlife, Inc.
Anesthesiology · 59d
Cleared Dec 04, 1978
VALVE, VENT-AWAY TWO-WAY
K781920
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 21d
Cleared May 23, 1977
ADAPTER, VALVE, ONE WAY BE-130-22
K770627
Instrumentation Industries, Inc.
Anesthesiology · 49d

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 →