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) |
|---|---|---|---|
| Jan 25, 2007 | MAQUET Inc. Ventilator System SERVO-i V3.1 PC1777
Maquet Critical Care Terminated |
CBK | K010925 |
| Jan 11, 2007 | Viasys Respiratory Care, Inc. Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654 Terminated |
CBK | K993449 |
| Jan 11, 2007 | Viasys Respiratory Care, Inc. Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653 Terminated |
CBK | K993449 |
| Oct 19, 2006 | Respironics California Inc Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246 Terminated |
CBK | K981072 |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502 Terminated |
CBK | K022679 K052863 |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,
Reno, NV 89502 Terminated |
CBK | K022679 K052863 |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360, Terminated |
CBK | K022679 K052863 |
| Jul 1, 2006 | Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 Terminated |
CBK | K040862 |
| May 2, 2006 | Respironics California Inc Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by deliver Terminated |
CBK | K022750 |
| Apr 7, 2006 | Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System
(Ventilator, Continuous) Terminated |
CBK | K040862 |
| Feb 14, 2006 | Draeger Medical, Inc. Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator Terminated |
CBK | K974176 |
| Jan 6, 2006 | Respironics California Inc The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuu Terminated |
CBK | K022750 |
| Nov 23, 2005 | Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who requ Terminated |
CBK | K002881 K010608 +2 |
| Nov 23, 2005 | Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who requ Terminated |
CBK | K002881 K010608 +2 |
| Nov 23, 2005 | Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who req Terminated |
CBK | K002881 K010608 +2 |
| Oct 15, 2005 | Event Medical INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian Terminated |
CBK | None listed |
| Aug 17, 2005 | Newport Medical Instruments Inc Newport HT50 All Purpose Ventilator Terminated |
CBK | K992133 |
| Aug 6, 2005 | Puritan Bennett Puritan Bennett 840 Series Ventilator Power Supply
Model/Catalog Numbers: 4-076314-00; 4-076314-SP Terminated |
CBK | K970460 |
| Jun 8, 2005 | Maquet Inc Servo-i Ventilator Terminated |
CBK | K040221 |
| Mar 8, 2005 | Maquet Inc Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, S Terminated |
CBK | K902859 K970839 |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio-Med Dental Breathing Circuit
Product NUmber: DENTL Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio-Med Patient Breathing Circuit
Product NUmber: 3030-5
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 3030-5
PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-= Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Pneumotach, Disposable (B)
Catalog Number: 4408
Labeled in part:
SINGLE USE CATALOG NO.4408
PNEUMOTACH, DISPOSABLE (B)
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=- Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-9
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A-9
PATIENT BREATHING CIRCUIT
=-=-=- Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-7
Labeled in part:
ONE SET - SINGLE USE ATALOG NO. 8002A-7
PATIENT BREATHING CIRCUIT
=-=-= Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A
PATIENT BREATHING CIRCUIT
=-=-=- Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 80015
Labeled in part:
DO NOT REUSE DISPOSABLE
DISPOSABLE PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
CONTENT Terminated |
CBK | None listed |
| Jan 29, 2005 | Bio-Med Devices, Inc. Bio Med Devices Patient Breathing Circuit
Catalog Number: 80011
Labeled in part: '':PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42 Terminated |
CBK | None listed |
| Jan 28, 2005 | Nellcor Puritan Bennett Inc Model 740 and 760 series Ventilators. Terminated |
CBK | K964540 K984379 |
| Jan 28, 2005 | Nellcor Puritan Bennett Inc Internal Battery for Puritan Bennett 700 Series Ventilator. Terminated |
CBK | K964540 K984379 |
| Sep 28, 2004 | Cardinal Health 203, Inc The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for u Terminated |
CBK | K002881 K010608 +3 |
| Jul 28, 2004 | Respironics California Inc Esprit Ventilator Terminated |
CBK | K001208 K023350 +2 |
| Jul 20, 2004 | Sechrist Industries Inc Infant Ventilators with Electronic Manometer.
Models IV-100B; IV-200 and IV-200 SAVI. Terminated |
CBK | K811141 K833982 +1 |
| Jul 20, 2004 | Respironics California Inc Espirit Ventilator, Model V1000
Continuous Ventilator with Respiratory Mechanics Terminated |
CBK | K981072 |
| Jul 20, 2004 | Respironics California Inc Esprit Ventilator. Terminated |
CBK | None listed |
| Jun 27, 2003 | Draeger Medical, Inc. Evita 4 Continuous Ventilator Terminated |
CBK | K010093 |
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