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 Apr 23, 2014
NASAL MASK, NASAL MASK, FULL FACE MASK
K133009
BMC Medical Co., Ltd.
Anesthesiology · 210d
Cleared Jan 13, 2014
K SERIES CPAP SYSTEMS
K130828
Curative Medical, Inc.
Anesthesiology · 293d
Cleared Jan 13, 2014
S9 CRONULLA FOR HER
K132606
Resmed, Ltd.
Anesthesiology · 146d
Cleared Dec 23, 2013
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
K131901
3B Medical, Inc.
Anesthesiology · 181d
Cleared Dec 20, 2013
AIRFIT N10
K132887
Resmed, Ltd.
Anesthesiology · 95d
Cleared Dec 06, 2013
K SERIES CPAP SYSTEMS
K131702
Curative Medical, Inc.
Anesthesiology · 178d
Cleared Dec 06, 2013
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
K132967
3B Medical, Inc.
Anesthesiology · 77d
Cleared Nov 20, 2013
BRONCHOSCOPY ELBOW
K132168
Respironics, Inc.
Anesthesiology · 131d
Cleared Oct 21, 2013
SWIFT AIR
K132013
Resmed, Ltd.
Anesthesiology · 112d
Cleared Oct 18, 2013
REMSTAR AUTO A-FLEX HT
K131982
Respironics, Inc.
Anesthesiology · 112d
Cleared Oct 17, 2013
TRANSCEND AUTO
K132127
Somnetics International, Inc.
Anesthesiology · 99d
Cleared Oct 16, 2013
NASAL COMFORT FREEDOM
K130686
Lakeview Sleep Center
Anesthesiology · 217d
Cleared Oct 11, 2013
SEATTLE - PAP
K131502
Seattle Childrens Hospital
Anesthesiology · 140d
Cleared Sep 27, 2013
BESTFIT2 NASAL MASK
K130663
Curative Medical, Inc.
Anesthesiology · 199d
Cleared Aug 22, 2013
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
K131707
3B Medical, Inc.
Anesthesiology · 72d
Cleared Jun 06, 2013
WIZARD 230 NASAL PILOW MASK
K121642
Apex Medical Corp.
Anesthesiology · 367d
Cleared Jun 05, 2013
F&P SIMPLUS FULL FACE MASK
K130328
Fisher & Paykel Healthcare Limited
Anesthesiology · 114d
Cleared May 24, 2013
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
K130481
Circadiance, LLC
Anesthesiology · 88d
Cleared May 21, 2013
REMSTAR SE
K130077
Respironics, Inc.
Anesthesiology · 127d
Cleared May 17, 2013
BREATHE CPAP SYSTEM
K130037
Breathe Technologies, Inc.
Anesthesiology · 130d
Cleared Mar 29, 2013
SWIFT FX NANO
K123789
Resmed, Ltd.
Anesthesiology · 109d
Cleared Mar 14, 2013
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
K121747
Intersurgical Incorporated
Anesthesiology · 273d
Cleared Mar 13, 2013
K SERIES CPAP SYSTEMS
K123897
Curative Medical, Inc.
Anesthesiology · 85d
Cleared Mar 06, 2013
KANGAROO NASAL MASK
K122847
Respironics, Inc.
Anesthesiology · 169d