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) |
|---|---|---|---|
| Feb 5, 2015 | Covidien 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 |
CBK | K131252 |
| Dec 9, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU. Terminated |
CBK | K131252 |
| Dec 1, 2014 | Respironics 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 |
CBK | K001208 K023350 +3 |
| Oct 28, 2014 | Nellcor 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 |
CBK | K131252 |
| Oct 21, 2014 | Respironics 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 |
CBK | K001208 K023350 +2 |
| Sep 19, 2014 | CareFusion 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 |
CBK | K070594 |
| Jun 20, 2014 | Nellcor 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 |
CBK | K970460 |
| Jun 17, 2014 | Nellcor 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 |
CBK | K970460 |
| May 9, 2014 | Nellcor 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 |
CBK | None listed |
| Apr 14, 2014 | Newport 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 |
CBK | K090888 K111146 |
| Apr 12, 2014 | Del Mar Reynolds Medical, Ltd. SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. Terminated |
CBK | K113051 |
| Mar 28, 2014 | Draeger 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 |
CBK | K093632 K093633 |
| Mar 6, 2014 | Phillips 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 |
CBK | K083526 K093416 +1 |
| Jan 24, 2014 | Nellcor 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 |
CBK | K964540 K970460 +2 |
| Jan 24, 2014 | Nellcor 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 |
CBK | K964540 K970460 +2 |
| Jan 3, 2014 | Covidien 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 |
CBK | K001646 K020357 +4 |
| Nov 6, 2013 | Hamilton 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 |
CBK | K121225 |
| Sep 27, 2013 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Aug 26, 2013 | Respironics California Inc Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 Terminated |
CBK | K001208 K023350 +3 |
| Jul 19, 2013 | Del 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 |
CBK | K113051 |
| Apr 26, 2013 | Newport 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 |
CBK | K090888 K111146 |
| Apr 26, 2013 | Maquet 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 |
CBK | K041223 |
| Mar 20, 2013 | Del 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 |
CBK | K003251 K101850 |
| Jan 31, 2013 | Hamilton 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 |
CBK | K120670 |
| Aug 7, 2012 | Impact 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 |
CBK | K103318 |
| Jul 23, 2012 | Respironics, 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 |
CBK | K083526 K093416 +1 |
| Jul 16, 2012 | CareFusion 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 |
CBK | K070594 |
| Jun 17, 2012 | GE Healthcare, LLC GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. Terminated |
CBK | K023366 |
| Apr 3, 2012 | Maquet 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 |
CBK | K041223 |
| Apr 3, 2012 | Maquet 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 |
CBK | K041223 |
| Mar 7, 2012 | Hamilton 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 |
CBK | K103803 |
| Feb 21, 2012 | Flight 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 |
CBK | K082724 K992133 |
| Jan 11, 2012 | Carefusion 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 |
CBK | K013642 K073069 +1 |
| Jan 11, 2012 | Respironics, 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 |
CBK | K083526 |
| Dec 2, 2011 | Maquet 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 |
CBK | K041223 |
| Dec 2, 2011 | Maquet 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 |
CBK | K041223 |
| Dec 2, 2011 | Maquet 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 |
CBK | K041223 |
| Oct 26, 2011 | CareFusion 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 |
CBK | K070594 |
| Aug 29, 2011 | Impact 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 |
CBK | None listed |
| Jun 23, 2011 | Maquet 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 |
CBK | None listed |
| Jun 23, 2011 | Maquet 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 |
CBK | None listed |
| Jun 8, 2011 | Newport 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 |
CBK | K053502 |
| Jun 2, 2011 | Newport 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 |
CBK | K090888 |
| May 27, 2011 | Newport 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 |
CBK | K082724 |
| May 26, 2011 | Newport 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 |
CBK | K992133 |
| May 26, 2011 | Newport 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 |
CBK | K992133 |
| Apr 8, 2011 | Hamilton 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 |
CBK | K081521 |
| Jan 27, 2011 | Biomed 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 |
CBK | None listed |
| Jan 27, 2011 | Biomed 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 |
CBK | None listed |
| Oct 7, 2010 | Draeger Medical Systems, Inc. Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969. Terminated |
CBK | K062267 |
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