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
49–72 of 461
Cleared Jul 05, 2019
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
K190254
Sleepnet Corporation
Anesthesiology · 148d
Cleared May 17, 2019
WiZARD 310/320 Series CPAP Mask
K182394
Apex Medical Corp.
Anesthesiology · 255d
Cleared May 07, 2019
Moore Park Mask
K183512
Resmed, Ltd.
Anesthesiology · 140d
Cleared Jan 04, 2019
Care Orchestrator
K181053
Respironics, Inc.
Anesthesiology · 259d
Cleared Nov 30, 2018
Transcend 365 miniCPAP System
K180388
Somnetics International, Inc.
Anesthesiology · 290d
Cleared Aug 08, 2018
F&P SleepStyle
K173193
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 310d
Cleared Jun 15, 2018
Scone Mask
K180497
Resmed, Ltd.
Anesthesiology · 109d
Cleared Mar 30, 2018
Bleep DreamPort
K172335
Snapcpap
Anesthesiology · 240d
Cleared Jan 03, 2018
AirFit F20
K170924
Resmed, Ltd.
Anesthesiology · 280d
Cleared Sep 28, 2017
AirFit N20
K171212
Resmed, Ltd.
Anesthesiology · 156d
Cleared Sep 05, 2017
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
K163464
Bmc Medical., Ltd.
Anesthesiology · 270d
Cleared Mar 15, 2017
SleepWeaver 3D Nasal Mask
K162905
Circadiance, LLC
Anesthesiology · 149d
Cleared Jan 24, 2017
F&P InfoSmart
K161686
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 221d
Cleared Jan 18, 2017
F&P Brevida™ Nasal Pillows Mask
K161412
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 243d
Cleared Dec 15, 2016
Menai System
K160836
Resmed, Ltd.
Anesthesiology · 265d
Cleared Nov 17, 2016
AirFit N20
K161978
Resmed, Ltd.
Anesthesiology · 122d
Cleared Nov 10, 2016
iCodeConnect
K160127
3B Medical, Inc.
Anesthesiology · 295d
Cleared Sep 20, 2016
F&P Eson 2 Nasal Mask
K153505
Fisher & Paykel Healthcare Limited
Anesthesiology · 288d
Cleared Sep 09, 2016
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K160822
Resmed, Ltd.
Anesthesiology · 169d
Cleared Sep 08, 2016
Luna CPAP and Auto CPAP System
K153387
3B Medical, Inc.
Anesthesiology · 290d
Cleared May 13, 2016
AirFit F20
K153563
Resmed, Ltd.
Anesthesiology · 151d
Cleared May 02, 2016
AirFit N20
K153673
Resmed, Ltd.
Anesthesiology · 133d
Cleared Apr 15, 2016
Simple T Pediatric Nasal Mask
K151120
Respironics, Inc.
Anesthesiology · 354d
Cleared Apr 05, 2016
SleepWeaver Advance Pediatric Nasal CPAP Mask
K151683
Circadiance, LLC
Anesthesiology · 288d