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
Cleared
Apr 23, 2014
NASAL MASK, NASAL MASK, FULL FACE MASK
BMC Medical Co., Ltd.
Anesthesiology
210d
Cleared
Jan 13, 2014
K SERIES CPAP SYSTEMS
Curative Medical, Inc.
Anesthesiology
293d
Cleared
Jan 13, 2014
S9 CRONULLA FOR HER
Resmed, Ltd.
Anesthesiology
146d
Cleared
Dec 23, 2013
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
3B Medical, Inc.
Anesthesiology
181d
Cleared
Dec 20, 2013
AIRFIT N10
Resmed, Ltd.
Anesthesiology
95d
Cleared
Dec 06, 2013
K SERIES CPAP SYSTEMS
Curative Medical, Inc.
Anesthesiology
178d
Cleared
Dec 06, 2013
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
3B Medical, Inc.
Anesthesiology
77d
Cleared
Nov 20, 2013
BRONCHOSCOPY ELBOW
Respironics, Inc.
Anesthesiology
131d
Cleared
Oct 21, 2013
SWIFT AIR
Resmed, Ltd.
Anesthesiology
112d
Cleared
Oct 18, 2013
REMSTAR AUTO A-FLEX HT
Respironics, Inc.
Anesthesiology
112d
Cleared
Oct 17, 2013
TRANSCEND AUTO
Somnetics International, Inc.
Anesthesiology
99d
Cleared
Oct 16, 2013
NASAL COMFORT FREEDOM
Lakeview Sleep Center
Anesthesiology
217d
Cleared
Oct 11, 2013
SEATTLE - PAP
Seattle Childrens Hospital
Anesthesiology
140d
Cleared
Sep 27, 2013
BESTFIT2 NASAL MASK
Curative Medical, Inc.
Anesthesiology
199d
Cleared
Aug 22, 2013
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
3B Medical, Inc.
Anesthesiology
72d
Cleared
Jun 06, 2013
WIZARD 230 NASAL PILOW MASK
Apex Medical Corp.
Anesthesiology
367d
Cleared
Jun 05, 2013
F&P SIMPLUS FULL FACE MASK
Fisher & Paykel Healthcare Limited
Anesthesiology
114d
Cleared
May 24, 2013
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
Circadiance, LLC
Anesthesiology
88d
Cleared
May 21, 2013
REMSTAR SE
Respironics, Inc.
Anesthesiology
127d
Cleared
May 17, 2013
BREATHE CPAP SYSTEM
Breathe Technologies, Inc.
Anesthesiology
130d
Cleared
Mar 29, 2013
SWIFT FX NANO
Resmed, Ltd.
Anesthesiology
109d
Cleared
Mar 14, 2013
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
Intersurgical Incorporated
Anesthesiology
273d
Cleared
Mar 13, 2013
K SERIES CPAP SYSTEMS
Curative Medical, Inc.
Anesthesiology
85d
Cleared
Mar 06, 2013
KANGAROO NASAL MASK
Respironics, Inc.
Anesthesiology
169d