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) |
|---|---|---|---|
| Aug 10, 2010 | CareFusion 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 |
CBK | K083688 |
| Jun 24, 2010 | Respironics, 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 |
CBK | K083526 |
| May 19, 2010 | Newport 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 |
CBK | K053502 |
| Feb 25, 2010 | CareFusion 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 |
CBK | K070594 |
| Jan 5, 2010 | MAQUET Inc. Maquet Servo Ventilator SV900C/D/E (SV900)
Siemens-Elema AB, Solna, Sweden Terminated |
CBK | K871254 K884520 |
| Jan 5, 2010 | MAQUET Inc. Maquet Servo Ventilator 300/300A (SV300)
Siemens - Elema AB, Terminated |
CBK | K902859 K970839 |
| Sep 4, 2009 | Newport 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 |
CBK | K053502 |
| Aug 11, 2009 | Respironics California Inc Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456. Terminated |
CBK | K001208 K034040 +3 |
| May 14, 2009 | Draeger Medical, Inc. Carina Home Ventilator.
The device is used as a continuous respirator/ventilator for home use. Terminated |
CBK | K060705 |
| May 12, 2009 | MAQUET 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 |
CBK | K902859 K970839 |
| Feb 3, 2009 | MAQUET 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 |
CBK | K970839 |
| Oct 27, 2008 | Draeger Medical, Inc. Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300. Terminated |
CBK | K062267 |
| Sep 24, 2008 | GE 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 |
CBK | K062710 |
| Sep 23, 2008 | MAQUET 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 |
CBK | K041223 |
| Sep 23, 2008 | MAQUET 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 |
CBK | K041223 |
| Sep 20, 2008 | Draeger Medical, Inc. Evita XL Critical Care Ventilator. Continuous (Respirator) Terminated |
CBK | K051263 |
| Sep 20, 2008 | Draeger Medical, Inc. Evita 4 Critical Care Ventilator. Continuous (Respirator) Terminated |
CBK | K010093 |
| Sep 20, 2008 | Draeger Medical, Inc. Evita 2 dura Critical Care Ventilator. Continuous (Respirator) Terminated |
CBK | K010093 |
| Sep 18, 2008 | Respironics, Inc. Power Board Kit for use with the PLV-100 Portable Lifecare repairs Terminated |
CBK | K832467 |
| Sep 18, 2008 | Respironics, 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 |
CBK | K832467 |
| Sep 17, 2008 | Respironics California Inc Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. Terminated |
CBK | K001208 K023350 +3 |
| Sep 17, 2008 | Respironics California Inc Esprit Power Supply Snubber Board Assembly FRU, PN 1036236
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. Terminated |
CBK | K001208 K023350 +3 |
| Sep 17, 2008 | Respironics California Inc Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. Terminated |
CBK | K001208 K023350 +3 |
| Sep 16, 2008 | Covidien Limited Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA Terminated |
CBK | K970460 |
| Aug 16, 2008 | Datex - 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 |
CBK | K062710 |
| Aug 13, 2008 | Cardinal 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 |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal Health 203, Inc Replacement Kit, Power PCBA with Memory PCBA. REF 14425.
Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Terminated |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal Health 203, Inc Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Terminated |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal 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 |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal 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 |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal 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 |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal 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 |
CBK | K002881 K010508 +3 |
| Aug 13, 2008 | Cardinal 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 |
CBK | K002881 K010508 +3 |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version) Terminated |
CBK | K013642 K022674 +1 |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) Terminated |
CBK | K013642 K022674 +1 |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) Terminated |
CBK | K013642 K022674 +1 |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version) Terminated |
CBK | K013642 K022674 +1 |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) Terminated |
CBK | K013642 K022674 +1 |
| Apr 24, 2008 | Respironics, 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 |
CBK | K842876 K982454 |
| Apr 24, 2008 | Respironics, 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 |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, 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 |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, 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 |
CBK | K842876 |
| Apr 24, 2008 | Respironics, 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 |
CBK | K842876 |
| Sep 19, 2007 | Newport Medical Instruments Inc Newport HT50 Ventilator (all Models) Terminated |
CBK | K992133 |
| May 10, 2007 | Datex - 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 |
CBK | K060862 |
| Apr 24, 2007 | Nellcor 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 |
CBK | K970460 |
| Mar 20, 2007 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc. Terminated |
CBK | K032451 |
| Feb 10, 2007 | MAQUET Inc. Ventilator System Servo-i V3.1
Maquet Critical Care
PC1771 Terminated |
CBK | None listed |
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