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)
Feb 5, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations
Terminated
CBKK131252
Dec 9, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Terminated
CBKK131252
Dec 1, 2014Respironics California Inc
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Inten
Terminated
CBKK001208
K023350 +3
Oct 28, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU)
Terminated
CBKK131252
Oct 21, 2014Respironics California Inc
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended f
Terminated
CBKK001208
K023350 +2
Sep 19, 2014CareFusion 203, Inc.
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It i
Terminated
CBKK070594
Jun 20, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patien
Terminated
CBKK970460
Jun 17, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part
Terminated
CBKK970460
May 9, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and mon
Terminated
CBKNone listed
Apr 14, 2014Newport Medical Instruments Inc
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ven
Terminated
CBKK090888
K111146
Apr 12, 2014Del Mar Reynolds Medical, Ltd.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Terminated
CBKK113051
Mar 28, 2014Draeger Medical Systems, Inc.
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of
Terminated
CBKK093632
K093633
Mar 6, 2014Phillips Respironics, Inc.
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended fo
Terminated
CBKK083526
K093416 +1
Jan 24, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen senso
Terminated
CBKK964540
K970460 +2
Jan 24, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient
Terminated
CBKK964540
K970460 +2
Jan 3, 2014Covidien
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Terminated
CBKK001646
K020357 +4
Nov 6, 2013Hamilton Medical, Inc.
HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to
Terminated
CBKK121225
Sep 27, 2013Carefusion 211 Inc dba Carefusion
Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (r
Terminated
CBKK013642
K073069 +1
Aug 26, 2013Respironics California Inc
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Terminated
CBKK001208
K023350 +3
Jul 19, 2013Del Mar Reynolds Medical, Ltd.
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circu
Terminated
CBKK113051
Apr 26, 2013Newport Medical Instruments Inc
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or inter
Terminated
CBKK090888
K111146
Apr 26, 2013Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for
Terminated
CBKK041223
Mar 20, 2013Del Mar Reynolds Medical, Ltd.
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation
Terminated
CBKK003251
K101850
Jan 31, 2013Hamilton Medical Inc
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Terminated
CBKK120670
Aug 7, 2012Impact Instrumentation, Inc.
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by
Terminated
CBKK103318
Jul 23, 2012Respironics, Inc.
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilatio
Terminated
CBKK083526
K093416 +1
Jul 16, 2012CareFusion 203, Inc.
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and tran
Terminated
CBKK070594
Jun 17, 2012GE Healthcare, LLC
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Terminated
CBKK023366
Apr 3, 2012Maquet Inc.
Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Terminated
CBKK041223
Apr 3, 2012Maquet Inc.
Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Terminated
CBKK041223
Mar 7, 2012Hamilton Medical Inc
HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventil
Terminated
CBKK103803
Feb 21, 2012Flight Medical Ltd.
V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a n
Terminated
CBKK082724
K992133
Jan 11, 2012Carefusion 211 Inc
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neon
Terminated
CBKK013642
K073069 +1
Jan 11, 2012Respironics, Inc.
Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and
Terminated
CBKK083526
Dec 2, 2011Maquet Inc.
Maquet PC Board PC1772 Spare Part Device Part number 64 67 620 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory in
Terminated
CBKK041223
Dec 2, 2011Maquet Inc.
Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory ins
Terminated
CBKK041223
Dec 2, 2011Maquet Inc.
Maquet Servo-i ventilator system Device Part number 64 87 800 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory ins
Terminated
CBKK041223
Oct 26, 2011CareFusion 203, Inc.
CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range
Terminated
CBKK070594
Aug 29, 2011Impact Instrumentation, Inc.
Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations
Terminated
CBKNone listed
Jun 23, 2011Maquet Inc.
Servo-s Ventilator Systems; Article number 66 40 440. Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to
Terminated
CBKNone listed
Jun 23, 2011Maquet Inc.
Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to
Terminated
CBKNone listed
Jun 8, 2011Newport Medical Instruments Inc
Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and moni
Terminated
CBKK053502
Jun 2, 2011Newport Medical Instruments Inc
Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who
Terminated
CBKK090888
May 27, 2011Newport Medical Instruments Inc
Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU The device is intended to provide continuous or intermittent mechanical ventilator support for the care of
Terminated
CBKK082724
May 26, 2011Newport Medical Instruments Inc
Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who
Terminated
CBKK992133
May 26, 2011Newport Medical Instruments Inc
Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation.
Terminated
CBKK992133
Apr 8, 2011Hamilton Medical Inc
Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option
Terminated
CBKK081521
Jan 27, 2011Biomed Devices
Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for
Terminated
CBKNone listed
Jan 27, 2011Biomed Devices
Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly
Terminated
CBKNone listed
Oct 7, 2010Draeger Medical Systems, Inc.
Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Terminated
CBKK062267

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