BYE · Class II · 21 CFR 868.5965

FDA Product Code BYE: Attachment, Breathing, Positive End Expiratory Pressure

Leading manufacturers include Vital Signs, Inc., Respironics, Inc. and Puritan Bennett Corp..

80
Total
80
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Attachment, Breathing, Positive End Expiratory Pressure Devices (Product Code BYE)

80 devices
1–24 of 80
Cleared Apr 29, 2016
Besmed PEEP Valve
K160112
Besmed Health Business Corp
Anesthesiology · 101d
Cleared Apr 14, 2014
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
K133957
Galemed Corp.
Anesthesiology · 112d
Cleared Mar 28, 2014
B&B BUBBLER
K133210
S & T Medical Technologies, Inc.
Anesthesiology · 162d
Cleared Aug 05, 2013
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
K122610
Sen MU Technology Co., Ltd.
Anesthesiology · 343d
Cleared Dec 27, 2011
O_TWO CPAP SYSTEM
K112546
O-Two Medical Technologies, Inc.
Anesthesiology · 117d
Cleared Sep 12, 2011
WATERPAP VALVE
K110713
Airways Development, LLC
Anesthesiology · 181d
Cleared Apr 20, 2011
NEOPIP PATIENT CIRCUIT WITH PEEP
K103833
Neoforce Group, Inc.
Anesthesiology · 111d
Cleared Aug 06, 2010
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
K092029
Draeger Medical AG & Co. KG
Anesthesiology · 396d
Cleared Aug 20, 2009
MERCURY CPAP
K090710
Mercury Medical
Anesthesiology · 155d
Cleared May 20, 2009
BABI*PLUS BUBBLE PAP VALVE
K090317
A Plus Medical
Anesthesiology · 100d
Cleared Mar 05, 2009
MERCURY MEDICAL PEEP VALVE
K081266
Mercury Enterprizes Dba Mercury Medical
Anesthesiology · 304d
Cleared May 09, 2008
PULMODYNE CHF FLOW GENERATOR SYSTEM
K080256
Pulmodyne
Anesthesiology · 99d
Cleared May 29, 2007
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
K070416
Neoforce Group, Inc.
Anesthesiology · 106d
Cleared Jun 06, 2005
KOO AMERICAS VALVE PEEP, MODEL KM-809
K050918
Koo Americas, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1999
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
K982283
Caradyne, Ltd.
Anesthesiology · 252d
Cleared Jan 22, 1999
EMS PEEP VALVES- ADJUSTABLE
K983920
Engineered Medical Systems
Anesthesiology · 79d
Cleared Jul 14, 1998
0-20 CM H20 PEEP VALVE
K981415
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 85d
Cleared Mar 19, 1997
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347
Instrumentation Industries, Inc.
Anesthesiology · 205d
Cleared Jan 23, 1997
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K962492
Nidek Medical Products, Inc.
Anesthesiology · 211d
Cleared Aug 13, 1996
PEEP VALVE
K961867
Medical Marketing Concepts
Anesthesiology · 90d
Cleared Mar 27, 1996
WESTMED CIRCULARIE PEP DEVICES
K955047
Westmed Intl.
Anesthesiology · 145d
Cleared Oct 26, 1995
SIMS CPAP SYSTEM
K953485
Smiths Industries Medical Systems, Inc.
Anesthesiology · 94d
Cleared Oct 26, 1995
KENDALL SHERIDAN CPAP SYSTEM
K953511
Kendall Healthcare Products Co. Div.Of Tyco Health
Anesthesiology · 92d
Cleared Apr 14, 1995
SYSTEM 22 VALVE
K950397
Turnkey Intergration USA, Inc.
Anesthesiology · 72d

About Product Code BYE - Regulatory Context