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
289–312 of 461
Cleared May 22, 2002
ORION NASAL CPAP SYSTEM
K020730
Bird Products Corp.
Anesthesiology · 77d
Cleared Jan 29, 2002
REMSTAR AUTO CPAP SYSTEM
K012554
Respironics, Inc.
Anesthesiology · 174d
Cleared Nov 02, 2001
MINIME NASAL MASK, MODEL P/N 50220
K013306
Sleepnet Corporation
Anesthesiology · 29d
Cleared Jul 24, 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034
Sensor Medics Corp.
Anesthesiology · 25d
Cleared Jun 28, 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714
Respironics, Inc.
Anesthesiology · 24d
Cleared Jun 25, 2001
ORACLE ORAL MASK
K003894
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 189d
Cleared May 04, 2001
REMREST
K002763
Medical Industries America, Inc.
Anesthesiology · 241d
Cleared Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
K010263
Respironics, Inc.
Anesthesiology · 59d
Cleared Oct 23, 2000
AERO-CLICK
K993094
Map Medizintechnik Fur Arzt Und Patient GmbH
Anesthesiology · 403d
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 May 26, 2000
SWIVEL ELBOW
K000215
Engineered Medical Systems
Anesthesiology · 123d
Cleared May 12, 2000
AIRPILOTMASK, MODEL TMS-900
K992192
Tiara Medical Systems, Inc.
Anesthesiology · 318d
Cleared Mar 07, 2000
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
K993584
Nellcor Puritan Bennett France Dvpt.
Anesthesiology · 137d
Cleared Jan 11, 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
K990856
Bird Products Corp.
Anesthesiology · 302d
Cleared Dec 01, 1999
CPAP/PRO CPAP INTERFACE
K992384
Stevenson Industries, Inc.
Anesthesiology · 138d
Cleared Nov 26, 1999
NASAL AIRE
K990659
Breathing Technologies Corp.
Anesthesiology · 270d
Cleared Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
K992969
Respironics, Inc.
Anesthesiology · 68d
Cleared Oct 27, 1999
IQ NASAL MASK, MODEL P/N 50160
K993269
Sleepnet Corporation
Anesthesiology · 27d
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