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
193–216 of 461
Cleared Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705
Respironics, Inc.
Anesthesiology · 190d
Cleared Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465
Respironics, Inc.
Anesthesiology · 28d
Cleared Sep 06, 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001
Puritan Bennett Corp.
Anesthesiology · 68d
Cleared Aug 03, 2000
BREAS PV 100 CPAP SYSTEM
K001553
Vital Signs, Inc.
Anesthesiology · 77d
Cleared Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994
Respironics, Inc.
Anesthesiology · 86d
Cleared Jan 11, 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
K990856
Bird Products Corp.
Anesthesiology · 302d
Cleared Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
K992969
Respironics, Inc.
Anesthesiology · 68d
Cleared Oct 27, 1999
ARIA LX CPAP SYSTEM
K993307
Respironics, Inc.
Anesthesiology · 23d
Cleared Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433
Respironics, Inc.
Anesthesiology · 15d
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 Jan 27, 1999
INVACARE CPAP
K982242
Invacare Corp.
Anesthesiology · 216d
Cleared Oct 16, 1998
SULLIVAN MIRAGE FULL FACE MASK
K982530
Resmed, Ltd.
Anesthesiology · 88d
Cleared Sep 01, 1998
SULLIVAN AUTOSET
K980721
Resmed, Ltd.
Anesthesiology · 189d
Cleared Jul 22, 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365
Nellcor Puritan Bennett, Inc.
Anesthesiology · 174d
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 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 Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
K953930
Respironics, Inc.
Anesthesiology · 406d