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
193–216 of 461
Cleared Oct 09, 2008
MODIFICATION TO MIRAGE MICRO
K081321
Resmed, Ltd.
Anesthesiology · 150d
Cleared Sep 12, 2008
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
K080209
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 228d
Cleared Sep 12, 2008
SLEEPSTYLE 200 AUTO SERIES HC254
K081029
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 154d
Cleared Apr 25, 2008
COMFORTGEL FULL FACE MASK
K073600
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 126d
Cleared Apr 08, 2008
S8 ESCAPE II
K080079
Resmed, Ltd.
Anesthesiology · 88d
Cleared Apr 01, 2008
VPAP ST
K080131
Resmed, Ltd.
Anesthesiology · 74d
Cleared Mar 20, 2008
SWIFT LT
K073638
Resmed, Ltd.
Anesthesiology · 85d
Cleared Jan 04, 2008
TXCONTROL
K072615
Resmed, Ltd.
Anesthesiology · 109d
Cleared Dec 27, 2007
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
K072996
Respironics, Inc.
Anesthesiology · 64d
Cleared Dec 19, 2007
PERFORMAX TOTAL FACE MASK
K072592
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 96d
Cleared Dec 13, 2007
MIRAGE MICRO
K072940
Resmed, Ltd.
Anesthesiology · 57d
Cleared Oct 10, 2007
MIRAGE MICRO
K071808
Resmed, Ltd.
Anesthesiology · 100d
Cleared Jul 13, 2007
RESTRAXX DATA CENTRE, MODEL R10
K070746
Resmed, Ltd.
Anesthesiology · 116d
Cleared Jul 10, 2007
VPAP AUTO WITH H3I
K071171
Resmed, Ltd.
Anesthesiology · 74d
Cleared May 04, 2007
APEX MEDICAL XT1 CPAP, MODEL 9S-005
K070609
Apex Medical Corp.
Anesthesiology · 60d
Cleared Apr 30, 2007
TWILIGHT FULL FACE MASK
K070321
Invacare Corp.
Anesthesiology · 87d
Cleared Mar 09, 2007
REMSTAR AFLEX CPAP SYSTEM
K063830
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 73d
Cleared Feb 02, 2007
MIRAGE LIBERTY FULL FACE MASK
K063011
Resmed, Ltd.
Anesthesiology · 123d
Cleared Feb 02, 2007
MIRAGE QUATTRO FULL FACE MASK
K063122
Resmed, Ltd.
Anesthesiology · 113d
Cleared Dec 22, 2006
OPUS HC482 DIRECT NASAL MASK
K063036
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 80d
Cleared Sep 08, 2006
VPAP MALIBU WITH H2I
K062291
Resmed, Ltd.
Anesthesiology · 32d
Cleared Sep 05, 2006
INVACARE'S TWILIGHT II NASAL MASKS
K061874
Invacare Corp.
Anesthesiology · 64d
Cleared Aug 29, 2006
FLEXIFIT HC432 FULL FACE MASK
K061236
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Jul 20, 2006
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
K061200
Resmed, Ltd.
Anesthesiology · 80d