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
121–144 of 461
Cleared Feb 27, 2013
QUATTRO AIR
K123979
Resmed, Ltd.
Anesthesiology · 63d
Cleared Feb 22, 2013
ZI BLOWER
K121374
Deshum Medical
Anesthesiology · 291d
Cleared Dec 06, 2012
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
K112079
Apex Medical Corp.
Anesthesiology · 504d
Cleared Nov 30, 2012
HARD SHELL VENTED NASAL MASK
K121321
Sleepnet Corporation
Anesthesiology · 212d
Cleared Nov 05, 2012
MINIME 2 NASAL MASK
K121692
Sleepnet Corporation
Anesthesiology · 151d
Cleared Nov 01, 2012
TAP PAP NASAL PILLOW MASK
K122350
Airway Management, Inc.
Anesthesiology · 90d
Cleared Oct 23, 2012
GEO
K121705
Resmed, Ltd.
Anesthesiology · 137d
Cleared Oct 09, 2012
REMSTAR SE
K122769
Respironics, Inc.
Anesthesiology · 29d
Cleared Oct 05, 2012
SIMPLE T NASAL MASK
K121631
Respironics, Inc.
Anesthesiology · 123d
Cleared Oct 02, 2012
ESON NASAL MASK
K121597
Fisher & Paykel Healthcare Limited
Anesthesiology · 124d
Cleared Jul 27, 2012
MOJO, VERASEAL
K120463
Sleepnet Corporation
Anesthesiology · 163d
Cleared Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562
Respironics, Inc.
Anesthesiology · 144d
Cleared Jul 16, 2012
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
K120920
Hsiner Company
Anesthesiology · 111d
Cleared Jul 02, 2012
K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
K120285
Curative Medical, Inc.
Anesthesiology · 153d
Cleared May 25, 2012
VPAP ADAPT
K113801
ResMed Corp
Anesthesiology · 155d
Cleared May 16, 2012
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
K120035
Apex Medical Corp.
Anesthesiology · 133d
Cleared Apr 27, 2012
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
K110629
3B Products, Inc.
Anesthesiology · 420d
Cleared Apr 24, 2012
SLEEPWEAVER ELAN NASAL CPAP MASK
K120757
Circadiance, LLC
Anesthesiology · 42d
Cleared Apr 20, 2012
EASYCARE TX SYSTEM (CONNEXUNS)
K113780
Resmed, Ltd.
Anesthesiology · 120d
Cleared Mar 30, 2012
SIMPLE T NASAL MASK
K120145
Respironics, Inc.
Anesthesiology · 72d
Cleared Feb 23, 2012
PILAIRO NASAL PILLOWS MASK
K120027
Fisher & Paykel Healthcare Limited
Anesthesiology · 51d
Cleared Feb 16, 2012
3B WILLOW
K112271
3B Products, LLC
Anesthesiology · 192d
Cleared Jan 06, 2012
MIRAGE QUATTRO
K113127
Resmed, Ltd.
Anesthesiology · 74d
Cleared Dec 16, 2011
REMSTAR AUTO A-FLEX HT
K113068
Respironics, Inc.
Anesthesiology · 60d