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
169–192 of 461
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 Feb 12, 2010
COMFORTGEL NASAL MASK
K092835
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 150d
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 Sep 10, 2009
COMFORT TWIN NASAL MASK
K091843
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 80d
Cleared Sep 03, 2009
COMFORT TWIN NASAL MASK
K091066
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 142d
Cleared Aug 03, 2009
QUATTRO LT
K091129
Resmed, Ltd.
Anesthesiology · 105d
Cleared Aug 03, 2009
REMSTAR AUTO A-FLEX
K091319
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 90d
Cleared Jul 01, 2009
MINIME PEDIATRIC MASK
K090935
Sleepnet Corporation
Anesthesiology · 90d
Cleared May 29, 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
K091271
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 29d
Cleared May 15, 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112
Respironics, Inc.
Anesthesiology · 28d
Cleared May 08, 2009
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
K090243
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 95d
Cleared May 06, 2009
MIRAGE ECHO
K090490
ResMed Corp
Anesthesiology · 70d
Cleared Apr 22, 2009
APEX MEDICAL XT AUTO CPAP 9S-005200
K083656
Apex Medical Corp.
Anesthesiology · 133d
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 30, 2009
REVOLUTIONFULL FACE MASK
K082866
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 123d
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
Cleared Jan 02, 2009
RESSCAN-PRO
K082983
Resmed, Ltd.
Anesthesiology · 88d