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 Jun 23, 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034
Respironics, Inc.
Anesthesiology · 70d
Cleared May 02, 2006
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
K060273
Sleepnet Corporation
Anesthesiology · 89d
Cleared Feb 15, 2006
COMFORTLITE NASAL MASK
K053352
Respironics, Inc.
Anesthesiology · 75d
Cleared Feb 03, 2006
RES TRAXX DATA CENTER
K053205
Resmed, Ltd.
Anesthesiology · 79d
Cleared Nov 17, 2005
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
K051226
Cardinalhealth
Anesthesiology · 189d
Cleared Nov 04, 2005
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
K051583
Tiara Medical Systems, Inc.
Anesthesiology · 142d
Cleared Oct 20, 2005
M-SERIES PRO CPAP SYTEM
K052110
Respironics, Inc.
Anesthesiology · 77d
Cleared Aug 03, 2005
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K050994
Cardinalhealth
Anesthesiology · 106d
Cleared Jul 15, 2005
RES TRAXX DATA CENTER
K051314
Resmed, Ltd.
Anesthesiology · 56d
Cleared Jul 08, 2005
IMASK, MODELS 100, 200 AND 300
K051559
Vital Signs Colorado, Inc.
Anesthesiology · 25d
Cleared Jun 15, 2005
BIPAP AUTO
K050759
Respironics, Inc.
Anesthesiology · 83d
Cleared Jun 13, 2005
GOODKNIGHT 425ST
K050072
Nellcor Puritan Bennett, Inc.
Anesthesiology · 152d
Cleared May 25, 2005
CPAP HUMIDIFIER, MODEL HC238JHU
K050904
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 44d
Cleared May 10, 2005
PIONEER U121 SERIES CPAP
K041823
Merits Health Products Co., Ltd.
Anesthesiology · 308d
Cleared May 10, 2005
RESSCAN
K050775
Resmed, Ltd.
Anesthesiology · 43d
Cleared May 04, 2005
IT NASAL MASK
K050171
Innomed Technologies
Anesthesiology · 98d
Cleared Mar 16, 2005
ULTRA MIRAGE II MASK
K050359
Resmed, Ltd.
Anesthesiology · 30d
Cleared Mar 09, 2005
AURA CPAP SYSTEM
K042945
Aeiomed, Inc.
Anesthesiology · 135d
Cleared Mar 04, 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202
Salter Labs
Anesthesiology · 400d
Cleared Mar 01, 2005
RESMED MERIDIAN MASK
K050142
Resmed, Ltd.
Anesthesiology · 36d
Cleared Feb 11, 2005
DEVILBISS AUTOADJUST, MODEL 9054 SERIES
K043282
Sunrise Medical
Anesthesiology · 77d
Cleared Jan 28, 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607
Respironics, Inc.
Anesthesiology · 29d
Cleared Jan 19, 2005
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
K043382
Tiara Medical Systems, Inc.
Anesthesiology · 41d
Cleared Jan 14, 2005
DEVILBISS NASAL CPAP MASK, 9354 SERIES
K042455
Sunrise Medical
Anesthesiology · 126d