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
97–120 of 461
Cleared Jun 06, 2011
TRUBLUE NASAL MASK
K110405
Respironics, Inc.
Anesthesiology · 112d
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
Cleared Jun 09, 2010
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
K100772
Resmed, Ltd.
Anesthesiology · 83d
Cleared Apr 27, 2010
F&P ICON SERIES CPAP
K094040
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Feb 26, 2010
EASYCARE ONLINE
K093684
Resmed, Ltd.
Anesthesiology · 88d
Cleared Oct 02, 2009
EASYCARE TX, TX LINK
K092026
Resmed, Ltd.
Anesthesiology · 88d
Cleared Sep 28, 2009
S8 ASPEN WITH H4I PLUS
K091947
Resmed, Ltd.
Anesthesiology · 90d
Cleared Aug 03, 2009
QUATTRO LT
K091129
Resmed, Ltd.
Anesthesiology · 105d
Cleared May 15, 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112
Respironics, Inc.
Anesthesiology · 28d
Cleared Apr 13, 2009
SWIFT FX
K090244
Resmed, Ltd.
Anesthesiology · 70d
Cleared Mar 25, 2009
COMFORTLITE NASAL MASK
K082558
Respironics, Inc.
Anesthesiology · 202d
Cleared Mar 20, 2009
RES TRAXX ONLINE, MODEL: R14
K083816
Resmed, Ltd.
Anesthesiology · 88d
Cleared Mar 16, 2009
ZEST NASAL MASK
K083832
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 83d
Cleared Jan 13, 2009
VPAP AUTO WITH HUMIDAIRE 3I
K082605
Resmed, Ltd.
Anesthesiology · 127d
Cleared Jan 02, 2009
S8 ADVANCE
K082979
Resmed, Ltd.
Anesthesiology · 88d