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
313–336 of 461
Cleared Oct 18, 1999
OPAP
K991926
Opap, Inc.
Anesthesiology · 133d
Cleared Aug 13, 1999
INFANT FLOW SYSTEM
K991972
Sensor Medics Corp.
Anesthesiology · 63d
Cleared Aug 13, 1999
MONARCH II MINI MASK
K992336
Respironics, Inc.
Anesthesiology · 31d
Cleared Jul 26, 1999
SULLIVAN AUTOSET NASAL CPAP SYSTEM
K984428
Resmed, Ltd.
Anesthesiology · 234d
Cleared May 28, 1999
REUSABLE CONTOUR II NASAL MASK
K991648
Respironics, Inc.
Anesthesiology · 15d
Cleared Apr 14, 1999
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
K991150
Nellcor Puritan Bennett France Dvpt.
Anesthesiology · 8d
Cleared Feb 24, 1999
INFANT FLOW NCPAP MASKS
K984254
Sensor Medics Corp.
Anesthesiology · 89d
Cleared Jan 27, 1999
INVACARE CPAP
K982242
Invacare Corp.
Anesthesiology · 216d
Cleared Nov 17, 1998
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K980551
Nidek Medical Products, Inc.
Anesthesiology · 278d
Cleared Oct 16, 1998
SULLIVAN MIRAGE FULL FACE MASK
K982530
Resmed, Ltd.
Anesthesiology · 88d
Cleared Oct 14, 1998
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
K981744
W. Keith Thornton, D.D.S.
Anesthesiology · 149d
Cleared Sep 01, 1998
SULLIVAN AUTOSET
K980721
Resmed, Ltd.
Anesthesiology · 189d
Cleared Aug 04, 1998
NASAL INTERFACE MODEL 7910
K974453
Healthdyne Technologies, Inc.
Anesthesiology · 252d
Cleared Jul 22, 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365
Nellcor Puritan Bennett, Inc.
Anesthesiology · 174d
Cleared Jul 10, 1998
CPAP HUMIDIFIER (HC 200)
K973161
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 322d
Cleared Jun 29, 1998
MODEL 7410 VOYAGER
K974879
Healthdyne Technologies, Inc.
Anesthesiology · 181d
Cleared Jan 30, 1998
INFANT FLOW SYSTEM
K974303
Sensor Medics Corp.
Anesthesiology · 74d
Cleared Jan 28, 1998
EMS NASAL CPAP MASK
K972605
Engineered Medical Systems
Anesthesiology · 201d
Cleared Jul 31, 1997
TMS COMFORT SERIES NASAL CPAP MASK
K964092
Tiara Medical Systems, Inc.
Anesthesiology · 293d
Cleared Jun 20, 1997
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
K970771
Resmed, Ltd.
Anesthesiology · 109d
Cleared Jun 18, 1997
MORPHEE PLUS ALPHA
K964019
Nellcor Puritan Bennett, Inc.
Anesthesiology · 254d
Cleared May 09, 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516
Resmed, Ltd.
Anesthesiology · 87d
Cleared Apr 18, 1997
QUARTET CLINICAL SYSTEM
K963761
Respironics, Inc.
Anesthesiology · 212d
Cleared Apr 16, 1997
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
K970173
Healthdyne Technologies, Inc.
Anesthesiology · 90d