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 Mar 19, 1997
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347
Instrumentation Industries, Inc.
Anesthesiology · 205d
Cleared Oct 26, 1995
KENDALL SHERIDAN CPAP SYSTEM
K953511
Kendall Healthcare Products Co. Div.Of Tyco Health
Anesthesiology · 92d
Cleared Jan 05, 1993
AMBU SINGLE PATIENT USE PEEP VALVE
K923976
Ambu, Inc.
Anesthesiology · 151d
Cleared May 29, 1992
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K922178
Puritan Bennett Corp.
Anesthesiology · 21d
Cleared Sep 11, 1991
20CM/H20 PEEP VALVE
K912578
Vital Signs, Inc.
Anesthesiology · 91d
Cleared Jan 08, 1991
ADJUSTABLE PEEP VALVE
K904874
Vital Signs, Inc.
Anesthesiology · 70d
Cleared Sep 10, 1990
COMPANION 318 NASAL CPAP SYSTEM
K903764
Puritan Bennett Corp.
Anesthesiology · 21d
Cleared Sep 04, 1990
PEEP VALVE
K902062
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 119d
Cleared Sep 04, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125
Puritan Bennett Corp.
Anesthesiology · 50d
Cleared Aug 14, 1990
ONE-LUNG CPAP DEVICE
K901728
Vital Signs, Inc.
Anesthesiology · 120d
Cleared Mar 28, 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113
Respironics, Inc.
Anesthesiology · 78d
Cleared Jan 26, 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164
Puritan Bennett Corp.
Anesthesiology · 14d
Cleared Sep 18, 1989
DEVILBISS MODEL 7351 SERIES
K894424
Devilbiss Health Care, Inc.
Anesthesiology · 63d
Cleared Sep 08, 1989
CPAP MASK
K894690
Devilbiss Health Care, Inc.
Anesthesiology · 46d
Cleared Jun 23, 1989
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K893388
Devilbiss Health Care, Inc.
Anesthesiology · 53d
Cleared Dec 08, 1988
MODIFIED SANDERS BI-PAPEASY
K883825
Respironics, Inc.
Anesthesiology · 90d
Cleared Jun 24, 1988
NASAL CPAP SYSTEM
K881833
Healthdyne, Inc.
Anesthesiology · 56d
Cleared Apr 29, 1988
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614
Ohmeda Medical
Anesthesiology · 17d
Cleared Mar 04, 1988
ACKRAD PEDIATRIC C.P.A.P. SYSTEM
K880161
Ackrad Laboratories
Anesthesiology · 51d
Cleared Sep 15, 1987
SLEEP APNEA NASAL CPAP SYSTEM
K871693
Puritan Bennett Corp.
Anesthesiology · 139d
Cleared Jul 16, 1987
RESPIRONICS SANDERS BIPAPEASY
K871523
Respironics, Inc.
Anesthesiology · 87d
Cleared Jul 14, 1986
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K861758
Life Design Systems, Inc.
Anesthesiology · 69d
Cleared Feb 24, 1986
LDS PEEP VALVE
K854822
Life Design Systems, Inc.
Anesthesiology · 83d
Cleared Jan 15, 1986
CUSHION-FLEX TM-CPAP FACE MASK
K854458
Life Design Systems, Inc.
Anesthesiology · 70d

About Product Code BYE - Regulatory Context