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)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2019 | Vyaire 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 |
CBK | K163127 |
| Jul 19, 2019 | GE 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 |
CBK | K023366 |
| Jul 11, 2019 | Hamilton 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 |
CBK | K081521 K103803 +1 |
| Dec 18, 2018 | COVIDIEN 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 |
CBK | K162738 |
| Nov 30, 2018 | GE 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 |
CBK | K142679 |
| Aug 10, 2018 | Spacelabs 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 |
CBK | K113051 |
| Jun 28, 2018 | Datex-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 |
CBK | K142679 |
| Jun 12, 2018 | Philips 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 |
CBK | K111610 |
| Jun 1, 2018 | Datex-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 |
CBK | K142679 |
| Apr 26, 2018 | Draeger Medical, Inc. Carina Ventilator, ventilator. Catalog no. 5704110.
Long-term ventilator for treatment in hospitals by a qualified medical personnel. Terminated |
CBK | K072885 |
| Mar 12, 2018 | Hamilton 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 |
CBK | K161450 |
| Mar 12, 2018 | Hamilton 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 |
CBK | K121225 |
| Mar 9, 2018 | Hamilton 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 |
CBK | K161450 |
| Mar 9, 2018 | Hamilton 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 |
CBK | K140939 |
| Nov 21, 2017 | Covidien 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 |
CBK | K131252 |
| Jun 30, 2017 | ZOLL 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 |
CBK | K071526 K091238 +2 |
| Apr 10, 2017 | Newport 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 |
CBK | K090888 K111146 |
| Feb 8, 2017 | Del 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 |
CBK | K113051 |
| Nov 28, 2016 | Hamilton 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 |
CBK | K122438 |
| Aug 4, 2016 | Draeger 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 |
CBK | K062267 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jun 13, 2016 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| May 9, 2016 | Hamilton 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 |
CBK | K070513 K103803 +1 |
| Mar 17, 2016 | Covidien 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 |
CBK | K131252 |
| Mar 7, 2016 | Philips 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 |
CBK | K083526 K093416 +1 |
| Feb 25, 2016 | Draeger Medical, Inc. Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator.
Ventilation. Terminated |
CBK | K093632 K093633 |
| Feb 3, 2016 | Resmed 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 |
CBK | K133868 |
| Feb 3, 2016 | Draeger 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 |
CBK | K062267 K082600 +1 |
| Feb 3, 2016 | Draeger Medical, Inc. Emergency Transport Ventilator
Oxylog 2000 Plus Ventilator
Catalog Number: 5705080.
Volume controlled emergency and transport ventilator with pressure support. Terminated |
CBK | K062267 K082600 +1 |
| Jan 21, 2016 | GE 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 |
CBK | K023366 |
| Dec 23, 2015 | Draeger 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 |
CBK | K093632 K093633 |
| Nov 19, 2015 | Event 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 |
CBK | K130178 |
| Nov 4, 2015 | Hamilton 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 |
CBK | K131774 |
| Aug 14, 2015 | Draeger Medical, Inc. PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. Terminated |
CBK | K093632 K093633 |
| Aug 14, 2015 | Covidien 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 |
CBK | K131252 |
| Jul 10, 2015 | Hamilton 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 |
CBK | K103803 K131774 |
| Jun 10, 2015 | ResMed Ltd. Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. Terminated |
CBK | K133868 |
| May 26, 2015 | Carefusion 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 |
CBK | K103211 |
| Apr 20, 2015 | Del 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 |
CBK | K112729 |
| Mar 24, 2015 | GE 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 |
CBK | K111116 |
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