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
337–360 of 461
Cleared Mar 28, 1997
NASALFLAIR
K951944
Airways Ltd., Inc.
Anesthesiology · 702d
Cleared Jan 30, 1997
BIPAP DUET SYSTEM
K964363
Respironics, Inc.
Anesthesiology · 90d
Cleared Dec 05, 1996
WHISPER SWIVEL II EXHALATION PORT
K962203
Respironics, Inc.
Anesthesiology · 181d
Cleared Nov 14, 1996
PRESSURE VALVE
K963250
Respironics, Inc.
Anesthesiology · 87d
Cleared Oct 23, 1996
DPAP STEALTH SLEEPNET MODEL NUMBER 84000
K962713
Sleepnet Corporation
Anesthesiology · 103d
Cleared Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
K953930
Respironics, Inc.
Anesthesiology · 406d
Cleared Aug 15, 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
K961915
Respironics, Inc.
Anesthesiology · 90d
Cleared Aug 01, 1996
SULLIVAN VPAP II ST NASAL VPAP SYSTEM
K961783
Resmed, Ltd.
Anesthesiology · 85d
Cleared Jul 29, 1996
NITELIFE BI-LEVEL CPAP
K943207
Airsep Corp.
Anesthesiology · 755d
Cleared Jul 18, 1996
SOLO CPAP SYSTEM
K961626
Respironics, Inc.
Anesthesiology · 83d
Cleared Jul 02, 1996
RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM
K952429
Rescare , Ltd.
Anesthesiology · 405d
Cleared Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572
Respironics, Inc.
Anesthesiology · 268d
Cleared Jun 13, 1996
THE IMS DPAP MASK, IMS MODEL NUMBER 82000
K953697
Sleepnet Corporation
Anesthesiology · 310d
Cleared May 28, 1996
SULLIVAN NOSE & MOUTH MASK SYSTEM
K952475
Rescare , Ltd.
Anesthesiology · 364d
Cleared May 09, 1996
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
K960518
Puritan Bennett Corp.
Anesthesiology · 94d
Cleared May 07, 1996
CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K952966
Nidek Medical Products, Inc.
Anesthesiology · 315d
Cleared Feb 08, 1996
MODEL #7354
K950849
Devilbiss Health Care, Inc.
Anesthesiology · 349d
Cleared Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
K945938
Respironics, Inc.
Anesthesiology · 422d
Cleared Jan 31, 1996
MODEL 7355
K952491
Devilbiss Health Care, Inc.
Anesthesiology · 246d
Cleared Jan 31, 1996
GEL MASK
K954207
Respironics, Inc.
Anesthesiology · 146d
Cleared Jan 30, 1996
ARIA CPAP SYSTEM
K953341
Respironics, Inc.
Anesthesiology · 266d
Cleared Nov 13, 1995
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
K952292
Puritan Bennett Corp.
Anesthesiology · 181d
Cleared Sep 21, 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
K950331
Healthdyne, Inc.
Anesthesiology · 237d
Cleared Mar 29, 1995
SPECTRUM(TM) MASK
K936047
Respironics, Inc.
Anesthesiology · 464d