BYE · Class II · 21 CFR 868.5965

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

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

80
Total
80
Cleared
93d
Avg days
1976
Since
80 devices
25–48 of 80
Cleared Sep 03, 1993
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
K932799
Engineered Medical Systems
Anesthesiology · 86d
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 Jan 12, 1990
LIFECARE NASAL MASK KIT CAT. NO. 06-800
K894779
Lifecare Services, Inc.
Anesthesiology · 169d
Cleared Nov 15, 1989
C.P.A.P. VALVE AND C.P.P.A. KIT
K895360
Ballard Medical Products
Anesthesiology · 79d
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 Jun 01, 1989
EDENTEC MODEL 2860 PRESSURE METER
K891540
Edentec Corp.
Anesthesiology · 76d
Cleared Dec 08, 1988
MODIFIED SANDERS BI-PAPEASY
K883825
Respironics, Inc.
Anesthesiology · 90d
Cleared Aug 30, 1988
P.E.E.P. VALVE
K882219
Life Support Products, Inc.
Anesthesiology · 96d
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 25, 1987
ARIES
K873170
Mountain Medical Equipment, Inc.
Anesthesiology · 45d
Cleared Sep 15, 1987
SLEEP APNEA NASAL CPAP SYSTEM
K871693
Puritan Bennett Corp.
Anesthesiology · 139d