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
265–288 of 461
Cleared Jan 14, 2004
ORACLE ORAL MASK, MODEL HC451A
K033087
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 107d
Cleared Dec 04, 2003
MIRAGE ACTIVA MASK
K032916
Resmed, Ltd.
Anesthesiology · 73d
Cleared Dec 01, 2003
MULTI-STRAP FULL FACE MASK
K023683
Engineered Medical Systems
Anesthesiology · 395d
Cleared Oct 24, 2003
NASAL JACKS MASK
K032433
Resmed, Ltd.
Anesthesiology · 79d
Cleared Oct 16, 2003
AUTOSET SPIRIT SYSTEM
K032480
Resmed, Ltd.
Anesthesiology · 65d
Cleared Oct 15, 2003
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
K030985
Vital Signs, Inc.
Anesthesiology · 201d
Cleared Sep 09, 2003
ARABELLA NCPAP MASKS
K030563
Hamilton Medical AG
Anesthesiology · 200d
Cleared Aug 25, 2003
LYRA NASAL MASK
K031883
Sensor Medics Corp.
Anesthesiology · 68d
Cleared Aug 19, 2003
MIRAGE VISTA MASK
K031047
Resmed, Ltd.
Anesthesiology · 139d
Cleared Aug 15, 2003
VPAP III
K030843
Resmed, Ltd.
Anesthesiology · 151d
Cleared Jul 02, 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
K024191
Resmed, Ltd.
Anesthesiology · 194d
Cleared Jun 24, 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460
Respironics, Inc.
Anesthesiology · 47d
Cleared Jun 12, 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
K023559
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 232d
Cleared Jun 12, 2003
SINGLE USE ORAL MASK, MODEL HC455A
K023670
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 224d
Cleared Apr 09, 2003
MIRAGE ACTIVA MASK
K030798
Resmed, Ltd.
Anesthesiology · 27d
Cleared Feb 11, 2003
TWLIGHT, MODEL ISP 9600
K022642
Invacare Corp.
Anesthesiology · 187d
Cleared Jan 24, 2003
PEGASUS NASAL CPAP SYSTEM
K022192
Sensor Medics Corp.
Anesthesiology · 203d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023244
Resmed, Ltd.
Anesthesiology · 58d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023284
Resmed, Ltd.
Anesthesiology · 56d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023306
Resmed, Ltd.
Anesthesiology · 55d
Cleared Jul 16, 2002
AUTOSET SPIRIT CPAP SYSTEM
K013843
ResMed Corp
Anesthesiology · 238d
Cleared Jul 08, 2002
S7 ELITE CP AP SYSTEM
K013909
ResMed Corp
Anesthesiology · 224d
Cleared Jul 02, 2002
IQ NASAL MASK, MODEL 50160 REV. D
K021534
Sleepnet Corporation
Anesthesiology · 53d
Cleared Jun 19, 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
K021861
Respironics, Inc.
Anesthesiology · 13d