BZD · Class II · 21 CFR 868.5905

FDA Product Code BZD: Ventilator, Non-continuous (respirator)

FDA product code BZD covers non-continuous ventilators, also known as intermittent positive pressure breathing (IPPB) devices and home respiratory support equipment.

Unlike continuous ventilators, these devices deliver assisted breaths only when triggered by the patient or on an intermittent schedule. They are used for the treatment of chronic respiratory conditions, post-operative respiratory therapy, and as backup support for patients with mild ventilatory insufficiency.

BZD devices are Class II medical devices, regulated under 21 CFR 868.5905 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Resmed, Ltd., Respironics, Inc. and Fisher &Paykel Healthcare , Ltd..

461
Total
461
Cleared
155d
Avg days
1977
Since
461 devices
361–384 of 461
Cleared Feb 27, 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804
Puritan Bennett Corp.
Anesthesiology · 508d
Cleared Nov 28, 1994
POSITIVE AIRWAY PRESSURE SYSTEM
K933184
Innovative Medical Systems, Inc.
Anesthesiology · 516d
Cleared Nov 10, 1994
CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
K935979
Devilbiss Health Care, Inc.
Anesthesiology · 332d
Cleared Feb 17, 1994
REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
K931484
Portable Power Systems, Inc.
Anesthesiology · 330d
Cleared Sep 14, 1993
NASAL/ORAL MASK
K925587
Respironics, Inc.
Anesthesiology · 313d
Cleared Jul 21, 1993
TOTAL FACE MASK
K925920
Respironics, Inc.
Anesthesiology · 240d
Cleared Apr 09, 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590
Puritan Bennett Corp.
Anesthesiology · 263d
Cleared Dec 07, 1992
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699
Respironics, Inc.
Anesthesiology · 313d
Cleared Oct 18, 1991
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465
Vital Signs, Inc.
Anesthesiology · 198d
Cleared Sep 23, 1991
LIFECARE CPAP-100
K912224
Lifecare Services, Inc.
Anesthesiology · 126d
Cleared Aug 09, 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856
Respironics, Inc.
Anesthesiology · 105d
Cleared Jul 30, 1991
SALTER LABS INFANT NASAL CPAP CANNULA
K912434
Salter Labs
Anesthesiology · 57d
Cleared Jun 24, 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780
Ackrad Laboratories
Anesthesiology · 63d
Cleared May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404
Medtronic Vascular
Anesthesiology · 161d
Cleared May 13, 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194
Puritan Bennett Corp.
Anesthesiology · 117d
Cleared May 01, 1991
SLEEPER MASK SYSTEM
K904344
Devilbiss Health Care, Inc.
Anesthesiology · 219d
Cleared Apr 23, 1991
SLEEPAP
K905593
Medical Industries America, Inc.
Anesthesiology · 131d
Cleared Mar 26, 1991
DEVILBISS MODEL 7352 SERIES
K904766
Devilbiss Health Care, Inc.
Anesthesiology · 155d
Cleared Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540
Respironics, Inc.
Anesthesiology · 50d
Cleared Oct 30, 1989
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
K895031
Ackrad Laboratories
Anesthesiology · 83d
Cleared May 14, 1987
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K871351
Holter-Hausner Intl.
Anesthesiology · 38d
Cleared Apr 21, 1987
C.P.A.P. NASAL CANNULA
K871157
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 28d
Cleared Dec 15, 1986
BIRD NIGHTBIRD NASAL CPAP SYSTEM
K863746
Bird Products Corp.
Anesthesiology · 82d
Cleared Nov 14, 1986
FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
K862448
Life Design Systems, Inc.
Anesthesiology · 140d