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
Cleared
Aug 15, 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
Respironics, Inc.
Anesthesiology
90d
Cleared
Aug 01, 1996
SULLIVAN VPAP II ST NASAL VPAP SYSTEM
Resmed, Ltd.
Anesthesiology
85d
Cleared
Jul 18, 1996
SOLO CPAP SYSTEM
Respironics, Inc.
Anesthesiology
83d
Cleared
Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
Respironics, Inc.
Anesthesiology
268d
Cleared
May 09, 1996
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
Puritan Bennett Corp.
Anesthesiology
94d
Cleared
Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
Respironics, Inc.
Anesthesiology
422d
Cleared
Jan 31, 1996
GEL MASK
Respironics, Inc.
Anesthesiology
146d
Cleared
Jan 30, 1996
ARIA CPAP SYSTEM
Respironics, Inc.
Anesthesiology
266d
Cleared
Nov 13, 1995
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
Puritan Bennett Corp.
Anesthesiology
181d
Cleared
Sep 21, 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
Healthdyne, Inc.
Anesthesiology
237d
Cleared
Mar 29, 1995
SPECTRUM(TM) MASK
Respironics, Inc.
Anesthesiology
464d
Cleared
Feb 27, 1995
PURITAN-BENNETT COMPANION 320 I/E
Puritan Bennett Corp.
Anesthesiology
508d
Cleared
Sep 14, 1993
NASAL/ORAL MASK
Respironics, Inc.
Anesthesiology
313d
Cleared
Jul 21, 1993
TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
240d
Cleared
Apr 09, 1993
318A RESPIRATORY SUPPORT SYSTEM
Puritan Bennett Corp.
Anesthesiology
263d
Cleared
Dec 07, 1992
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
Respironics, Inc.
Anesthesiology
313d
Cleared
Oct 18, 1991
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
Vital Signs, Inc.
Anesthesiology
198d
Cleared
Aug 09, 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
Respironics, Inc.
Anesthesiology
105d
Cleared
Jul 30, 1991
SALTER LABS INFANT NASAL CPAP CANNULA
Salter Labs
Anesthesiology
57d
Cleared
Jun 24, 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
Ackrad Laboratories
Anesthesiology
63d
Cleared
May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
Medtronic Vascular
Anesthesiology
161d
Cleared
May 13, 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
Puritan Bennett Corp.
Anesthesiology
117d
Cleared
Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
Respironics, Inc.
Anesthesiology
50d
Cleared
Oct 30, 1989
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
Ackrad Laboratories
Anesthesiology
83d