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
217–240 of 461
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 18, 1996
SOLO CPAP SYSTEM
K961626
Respironics, Inc.
Anesthesiology · 83d
Cleared Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572
Respironics, Inc.
Anesthesiology · 268d
Cleared May 09, 1996
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
K960518
Puritan Bennett Corp.
Anesthesiology · 94d
Cleared Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
K945938
Respironics, Inc.
Anesthesiology · 422d
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
Cleared Feb 27, 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804
Puritan Bennett Corp.
Anesthesiology · 508d
Cleared Sep 14, 1993
NASAL/ORAL MASK
K925587
Respironics, Inc.
Anesthesiology · 313d
Cleared Jul 21, 1993
TOTAL FACE MASK
K925920
Respironics, Inc.
Anesthesiology · 240d
Cleared Apr 09, 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590
Puritan Bennett Corp.
Anesthesiology · 263d
Cleared Dec 07, 1992
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699
Respironics, Inc.
Anesthesiology · 313d
Cleared Oct 18, 1991
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465
Vital Signs, Inc.
Anesthesiology · 198d
Cleared Aug 09, 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856
Respironics, Inc.
Anesthesiology · 105d
Cleared Jul 30, 1991
SALTER LABS INFANT NASAL CPAP CANNULA
K912434
Salter Labs
Anesthesiology · 57d
Cleared Jun 24, 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780
Ackrad Laboratories
Anesthesiology · 63d
Cleared May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404
Medtronic Vascular
Anesthesiology · 161d
Cleared May 13, 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194
Puritan Bennett Corp.
Anesthesiology · 117d
Cleared Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540
Respironics, Inc.
Anesthesiology · 50d
Cleared Oct 30, 1989
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
K895031
Ackrad Laboratories
Anesthesiology · 83d