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
73–96 of 461
Cleared Jul 31, 2014
S9 GREENHILLS
K140279
Resmed, Ltd.
Anesthesiology · 178d
Cleared Jun 17, 2014
S9 WANDA VPAP ST
K140159
Resmed, Ltd.
Anesthesiology · 146d
Cleared Jun 09, 2014
AIRSOFT F15
K132901
Resmed, Ltd.
Anesthesiology · 266d
Cleared May 16, 2014
RESCAN
K140054
Resmed, Ltd.
Anesthesiology · 127d
Cleared Jan 13, 2014
S9 CRONULLA FOR HER
K132606
Resmed, Ltd.
Anesthesiology · 146d
Cleared Dec 20, 2013
AIRFIT N10
K132887
Resmed, Ltd.
Anesthesiology · 95d
Cleared Nov 20, 2013
BRONCHOSCOPY ELBOW
K132168
Respironics, Inc.
Anesthesiology · 131d
Cleared Oct 21, 2013
SWIFT AIR
K132013
Resmed, Ltd.
Anesthesiology · 112d
Cleared Oct 18, 2013
REMSTAR AUTO A-FLEX HT
K131982
Respironics, Inc.
Anesthesiology · 112d
Cleared May 21, 2013
REMSTAR SE
K130077
Respironics, Inc.
Anesthesiology · 127d
Cleared Mar 29, 2013
SWIFT FX NANO
K123789
Resmed, Ltd.
Anesthesiology · 109d
Cleared Mar 06, 2013
KANGAROO NASAL MASK
K122847
Respironics, Inc.
Anesthesiology · 169d
Cleared Feb 27, 2013
QUATTRO AIR
K123979
Resmed, Ltd.
Anesthesiology · 63d
Cleared Oct 23, 2012
GEO
K121705
Resmed, Ltd.
Anesthesiology · 137d
Cleared Oct 09, 2012
REMSTAR SE
K122769
Respironics, Inc.
Anesthesiology · 29d
Cleared Oct 05, 2012
SIMPLE T NASAL MASK
K121631
Respironics, Inc.
Anesthesiology · 123d
Cleared Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562
Respironics, Inc.
Anesthesiology · 144d
Cleared Apr 20, 2012
EASYCARE TX SYSTEM (CONNEXUNS)
K113780
Resmed, Ltd.
Anesthesiology · 120d
Cleared Mar 30, 2012
SIMPLE T NASAL MASK
K120145
Respironics, Inc.
Anesthesiology · 72d
Cleared Jan 06, 2012
MIRAGE QUATTRO
K113127
Resmed, Ltd.
Anesthesiology · 74d
Cleared Dec 16, 2011
REMSTAR AUTO A-FLEX HT
K113068
Respironics, Inc.
Anesthesiology · 60d
Cleared Dec 07, 2011
SWIFT FX BELLA
K112489
Resmed, Ltd.
Anesthesiology · 100d
Cleared Nov 16, 2011
TASMAN
K112393
Resmed, Ltd.
Anesthesiology · 89d
Cleared Aug 19, 2011
INFOSEND GSM
K110316
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 197d