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)
Aug 10, 2010CareFusion 203, Inc.
Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalat
Terminated
CBKK083688
Jun 24, 2010Respironics, Inc.
Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individ
Terminated
CBKK083526
May 19, 2010Newport Medical Instruments Inc
Newport e360 Ventilator The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, p
Terminated
CBKK053502
Feb 25, 2010CareFusion 203, Inc.
Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of indivi
Terminated
CBKK070594
Jan 5, 2010MAQUET Inc.
Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
Terminated
CBKK871254
K884520
Jan 5, 2010MAQUET Inc.
Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
Terminated
CBKK902859
K970839
Sep 4, 2009Newport Medical Instruments Inc
Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring fo
Terminated
CBKK053502
Aug 11, 2009Respironics California Inc
Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
Terminated
CBKK001208
K034040 +3
May 14, 2009Draeger Medical, Inc.
Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
Terminated
CBKK060705
May 12, 2009MAQUET Inc.
Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients.
Terminated
CBKK902859
K970839
Feb 3, 2009MAQUET Inc.
SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit
Terminated
CBKK970839
Oct 27, 2008Draeger Medical, Inc.
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
Terminated
CBKK062267
Sep 24, 2008GE Healthcare
GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the sys
Terminated
CBKK062710
Sep 23, 2008MAQUET Inc.
SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure
Terminated
CBKK041223
Sep 23, 2008MAQUET Inc.
SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure
Terminated
CBKK041223
Sep 20, 2008Draeger Medical, Inc.
Evita XL Critical Care Ventilator. Continuous (Respirator)
Terminated
CBKK051263
Sep 20, 2008Draeger Medical, Inc.
Evita 4 Critical Care Ventilator. Continuous (Respirator)
Terminated
CBKK010093
Sep 20, 2008Draeger Medical, Inc.
Evita 2 dura Critical Care Ventilator. Continuous (Respirator)
Terminated
CBKK010093
Sep 18, 2008Respironics, Inc.
Power Board Kit for use with the PLV-100 Portable Lifecare repairs
Terminated
CBKK832467
Sep 18, 2008Respironics, Inc.
PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breat
Terminated
CBKK832467
Sep 17, 2008Respironics California Inc
Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
Terminated
CBKK001208
K023350 +3
Sep 17, 2008Respironics California Inc
Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
Terminated
CBKK001208
K023350 +3
Sep 17, 2008Respironics California Inc
Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
Terminated
CBKK001208
K023350 +3
Sep 16, 2008Covidien Limited
Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
Terminated
CBKK970460
Aug 16, 2008Datex - Ohmeda, Inc
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to provide mechanical ventilation for adul
Terminated
CBKK062710
Aug 13, 2008Cardinal Health 203, Inc
Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Viasys healthcare, Pulmonetic Systems LTV 900 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight
Terminated
CBKK002881
K010508 +3
Aug 13, 2008Cardinal Health 203, Inc
Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightwei
Terminated
CBKK002881
K010508 +3
May 14, 2008Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)
Terminated
CBKK013642
K022674 +1
May 14, 2008Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version)
Terminated
CBKK013642
K022674 +1
May 14, 2008Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version)
Terminated
CBKK013642
K022674 +1
May 14, 2008Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version)
Terminated
CBKK013642
K022674 +1
May 14, 2008Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)
Terminated
CBKK013642
K022674 +1
Apr 24, 2008Respironics, Inc.
Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model n
Terminated
CBKK842876
K982454
Apr 24, 2008Respironics, Inc.
RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
CBKK842876
Apr 24, 2008Respironics, Inc.
RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
CBKK842876
Apr 24, 2008Respironics, Inc.
RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
CBKK842876
Apr 24, 2008Respironics, Inc.
Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
CBKK842876
Apr 24, 2008Respironics, Inc.
PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
CBKK842876
Apr 24, 2008Respironics, Inc.
Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
CBKK842876
Sep 19, 2007Newport Medical Instruments Inc
Newport HT50 Ventilator (all Models)
Terminated
CBKK992133
May 10, 2007Datex - Ohmeda, Inc
GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohm
Terminated
CBKK060862
Apr 24, 2007Nellcor Puritan Bennett
Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs indicate any combination of alpha cha
Terminated
CBKK970460
Mar 20, 2007Viasys Respiratory Care, Inc.dba Bird Products
VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
Terminated
CBKK032451
Feb 10, 2007MAQUET Inc.
Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
Terminated
CBKNone listed

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