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
145–168 of 461
Cleared Oct 20, 2005
M-SERIES PRO CPAP SYTEM
K052110
Respironics, Inc.
Anesthesiology · 77d
Cleared Jul 15, 2005
RES TRAXX DATA CENTER
K051314
Resmed, Ltd.
Anesthesiology · 56d
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
RESSCAN
K050775
Resmed, Ltd.
Anesthesiology · 43d
Cleared Mar 16, 2005
ULTRA MIRAGE II MASK
K050359
Resmed, Ltd.
Anesthesiology · 30d
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 Jan 28, 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607
Respironics, Inc.
Anesthesiology · 29d
Cleared Oct 08, 2004
MIRAGE SWIFT
K042403
Resmed, Ltd.
Anesthesiology · 35d
Cleared Aug 31, 2004
HC604 CPAP HUMIDIFIER
K041900
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 48d
Cleared Jul 15, 2004
RESMED HOSPITAL FULL FACE MASK
K041362
Resmed, Ltd.
Anesthesiology · 56d
Cleared Jul 01, 2004
RESMED S8 PIONEER CPAP SYSTEM
K041209
Resmed, Ltd.
Anesthesiology · 52d
Cleared Jun 30, 2004
IMASK TM
K041309
Vital Signs, Inc.
Anesthesiology · 44d
Cleared Jun 10, 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
K040941
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 59d
Cleared Jun 03, 2004
RESCONTROL II
K040944
Resmed, Ltd.
Anesthesiology · 52d
Cleared May 05, 2004
RESCAN
K034033
Resmed, Ltd.
Anesthesiology · 128d
Cleared May 05, 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
K040506
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 68d
Cleared May 05, 2004
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
K041010
Respironics, Inc.
Anesthesiology · 15d
Cleared Apr 22, 2004
OXYGEN DIVERTER VALVE
K033914
Resmed, Ltd.
Anesthesiology · 126d
Cleared Apr 02, 2004
RESMED HOSPITAL NASAL MASK
K040566
Resmed, Ltd.
Anesthesiology · 29d
Cleared Mar 12, 2004
INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064
Invacare Corp.
Anesthesiology · 344d
Cleared Mar 10, 2004
RESMED S8 PRIME CPAP SYSTEM
K033841
Resmed, Ltd.
Anesthesiology · 91d