ClearanceBrief
Panels › Anesthesiology › Product code CBK · Class 2

Ventilator, Continuous, Facility Use

Regulation 868.5895

4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
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Top companies in CBK

DateFirm and productCodeLinked 510(k)
Nov 25, 2019Vyaire Medical
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air an
Terminated
CBKK163127
Jul 19, 2019GE Healthcare, LLC
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-90
Terminated
CBKK023366
Jul 11, 2019Hamilton Medical AG
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and ne
Terminated
CBKK081521
K103803 +1
Dec 18, 2018COVIDIEN LLC
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The
Terminated
CBKK162738
Nov 30, 2018GE Healthcare, LLC
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical
Terminated
CBKK142679
Aug 10, 2018Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia
Terminated
CBKK113051
Jun 28, 2018Datex-Ohmeda, Inc.
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designe
Terminated
CBKK142679
Jun 12, 2018Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurney
Open, Classified
CBKK111610
Jun 1, 2018Datex-Ohmeda, Inc.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patient
Terminated
CBKK142679
Apr 26, 2018Draeger Medical, Inc.
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Terminated
CBKK072885
Mar 12, 2018Hamilton Medical AG
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Open, Classified
CBKK161450
Mar 12, 2018Hamilton Medical AG
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Open, Classified
CBKK121225
Mar 9, 2018Hamilton Medical AG
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configur
Terminated
CBKK161450
Mar 9, 2018Hamilton Medical AG
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive
Terminated
CBKK140939
Nov 21, 2017Covidien LLC
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042;
Terminated
CBKK131252
Jun 30, 2017ZOLL Medical Corporation
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or c
Terminated
CBKK071526
K091238 +2
Apr 10, 2017Newport Medical Instruments Inc
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilat
Terminated
CBKK090888
K111146
Feb 8, 2017Del Mar Reynolds Medical, Ltd.
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual
Terminated
CBKK113051
Nov 28, 2016Hamilton Medical, Inc.
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas o
Terminated
CBKK122438
Aug 4, 2016Draeger Medical, Inc.
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000
Terminated
CBKK062267
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breath
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathin
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of o
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predeter
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined perc
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined perc
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen
Terminated
CBKK013642
K073069 +1
Jun 13, 2016Carefusion 211 Inc dba Carefusion
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of
Terminated
CBKK013642
K073069 +1
May 9, 2016Hamilton Medical, Inc.
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and ped
Terminated
CBKK070513
K103803 +1
Mar 17, 2016Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invas
Terminated
CBKK131252
Mar 7, 2016Philips Respironics
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care o
Terminated
CBKK083526
K093416 +1
Feb 25, 2016Draeger Medical, Inc.
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Terminated
CBKK093632
K093633
Feb 3, 2016Resmed Corporation
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients
Terminated
CBKK133868
Feb 3, 2016Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and tra
Terminated
CBKK062267
K082600 +1
Feb 3, 2016Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
Terminated
CBKK062267
K082600 +1
Jan 21, 2016GE Medical Systems, LLC
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controll
Terminated
CBKK023366
Dec 23, 2015Draeger Medical, Inc.
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
Terminated
CBKK093632
K093633
Nov 19, 2015Event Medical LTD
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital
Terminated
CBKK130178
Nov 4, 2015Hamilton Medical, Inc.
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optio
Terminated
CBKK131774
Aug 14, 2015Draeger Medical, Inc.
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Terminated
CBKK093632
K093633
Aug 14, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respirato
Terminated
CBKK131252
Jul 10, 2015Hamilton Medical, Inc.
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant
Terminated
CBKK103803
K131774
Jun 10, 2015ResMed Ltd.
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Terminated
CBKK133868
May 26, 2015Carefusion 211 Inc dba Carefusion
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of o
Terminated
CBKK103211
Apr 20, 2015Del Mar Reynolds Medical, Ltd.
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediat
Terminated
CBKK112729
Mar 24, 2015GE Healthcare
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Terminated
CBKK111116

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