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
145–168 of 461
Cleared Dec 07, 2011
SWIFT FX BELLA
K112489
Resmed, Ltd.
Anesthesiology · 100d
Cleared Nov 22, 2011
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
K112220
Devilbiss Healthcare, LLC
Anesthesiology · 112d
Cleared Nov 16, 2011
SOYALA SILKGEL FULL FACE MASK
K112167
Weinmann Gerate Fur Medizin GmbH + Co. KG
Anesthesiology · 111d
Cleared Nov 16, 2011
TASMAN
K112393
Resmed, Ltd.
Anesthesiology · 89d
Cleared Oct 13, 2011
3B FLEX-LITE
K103434
3B Products, LLC
Anesthesiology · 324d
Cleared Oct 07, 2011
BABI PLUS INFANT NASAL CANNULA SYSTEM
K110471
A Plus Medical
Anesthesiology · 231d
Cleared Aug 19, 2011
INFOSEND GSM
K110316
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 197d
Cleared Aug 01, 2011
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
K110383
A Plus Medical
Anesthesiology · 172d
Cleared Jul 12, 2011
EASYFIT SILKGEL NASAL MASK
K110884
Weinmann Gerate Fur Medizin GmbH + Co. KG
Anesthesiology · 104d
Cleared Jun 30, 2011
S8 ASPEN WITH H4I PLUS
K111148
ResMed Corp
Anesthesiology · 69d
Cleared Jun 06, 2011
TRUBLUE NASAL MASK
K110405
Respironics, Inc.
Anesthesiology · 112d
Cleared May 17, 2011
IQ VENTILATION NASAL MASK
K102317
Sleepnet Corporation
Anesthesiology · 274d
Cleared May 06, 2011
APEX MEDICAL WIZARD SERIES CPAP MASK
K103174
Apex Medical Corp.
Anesthesiology · 191d
Cleared Mar 30, 2011
NEOPAP SYSTEM
K103410
Childrens Medical Ventures, LLC
Anesthesiology · 128d
Cleared Mar 24, 2011
PERFORMAX TOTAL FACE MASK
K103395
Respironics, Inc.
Anesthesiology · 125d
Cleared Mar 24, 2011
ZEST PETITE NASAL MASK
K103786
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 87d
Cleared Mar 18, 2011
S9 VPAP ADAPT WITH H5I
K102586
Resmed, Ltd.
Anesthesiology · 190d
Cleared Mar 16, 2011
MIRAGE MICRO
K110444
Resmed, Ltd.
Anesthesiology · 28d
Cleared Feb 17, 2011
GOLIFE NASAL MASK
K110008
Respironics, Inc.
Anesthesiology · 45d
Cleared Jan 05, 2011
S9 VPAP ST WITH H5I
K102513
Resmed, Ltd.
Anesthesiology · 126d
Cleared Dec 28, 2010
MIRAGE FX
K102746
Resmed, Ltd.
Anesthesiology · 96d
Cleared Dec 22, 2010
GOLIFE NASAL MASK
K102502
Respironics, Inc.
Anesthesiology · 112d
Cleared Dec 10, 2010
PIXI PEDIATRIC MASK
K102224
Resmed, Ltd.
Anesthesiology · 126d
Cleared Oct 08, 2010
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
K100011
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 277d