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
73–96 of 461
Cleared Jan 21, 2016
DeVilbiss DV6WM Wireless Modem
K152810
Devilbiss Healthcare, LLC
Anesthesiology · 115d
Cleared Jan 08, 2016
Sapphire
K152356
Respironics, Inc.
Anesthesiology · 141d
Cleared Sep 18, 2015
DeVilbiss Intellipap2/DeVilbiss BLUE
K143677
Devilbiss Healthcare, LLC
Anesthesiology · 268d
Cleared Sep 18, 2015
AF541 EE Full Face Mask
K150639
Respironics, Inc.
Anesthesiology · 191d
Cleared Sep 15, 2015
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
K150111
Apex Medical Corp.
Anesthesiology · 238d
Cleared Aug 24, 2015
Skynector CPAP Mask
K150685
Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.
Anesthesiology · 160d
Cleared Aug 05, 2015
CPAP Cannulaide
K143700
Salter Labs
Anesthesiology · 224d
Cleared Jul 21, 2015
Cloud9 System
K150365
Insleep Technologies, LLC
Anesthesiology · 159d
Cleared May 21, 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603
Resmed, Ltd.
Anesthesiology · 154d
Cleared Apr 22, 2015
LUNA CPAP AND AUTO-CPAP SYSTEM
K141770
3B Medical, Inc.
Anesthesiology · 295d
Cleared Feb 10, 2015
TI NASAL MASK
K140980
Respironics, Inc.
Anesthesiology · 300d
Cleared Jan 16, 2015
REVOLUTION FULLFACE MASK
K140580
Respironics Inc. (Dba Philips Respironics)
Anesthesiology · 316d
Cleared Jan 09, 2015
Revolution Full Face Mask
K142554
Respironics, Inc.
Anesthesiology · 120d
Cleared Oct 20, 2014
SIMPLE T YOUTH NASAL MASK
K140268
Respironics, Inc.
Anesthesiology · 250d
Cleared Oct 17, 2014
Z1 CPAP SYSTEM
K140929
Human Design Medical, LLC
Anesthesiology · 191d
Cleared Oct 17, 2014
ADVANTAGE
K141152
Stevenson Industries, Inc.
Anesthesiology · 165d
Cleared Oct 06, 2014
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
K141522
Apex Medical Corp.
Anesthesiology · 119d
Cleared Aug 25, 2014
3B RESMART BPAP 25A, BMC RESMART BPAP 25A
K133769
3B Medical, Inc.
Anesthesiology · 257d
Cleared Aug 04, 2014
DEVILBISS SMARTLINK II SYSTEM
K140880
Devilbiss Healthcare, LLC
Anesthesiology · 119d
Cleared Jul 31, 2014
S9 GREENHILLS
K140279
Resmed, Ltd.
Anesthesiology · 178d
Cleared Jun 17, 2014
S9 WANDA VPAP ST
K140159
Resmed, Ltd.
Anesthesiology · 146d
Cleared Jun 09, 2014
AIRSOFT F15
K132901
Resmed, Ltd.
Anesthesiology · 266d
Cleared May 16, 2014
RESCAN
K140054
Resmed, Ltd.
Anesthesiology · 127d
Cleared May 12, 2014
S9 ELOUERA
K140124
ResMed Corp
Anesthesiology · 116d