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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2003 | K030515 | HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS Hans Rudolph, Inc. | CBK |
| Jan 15, 2003 | K023289 | OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 Drager Medizintechnik GmbH | CBK |
| Jan 3, 2003 | K023135 | IMAGE3 SE DISPOSABLE FULL FACE MASK Respironics, Inc. | CBK |
| Dec 20, 2002 | K012691 | MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES Acutronic Medical Systems AG | CBK |
| Nov 22, 2002 | K021112 | INSPIRATION VENTILATOR SYSTEM eVent Medical, Ltd. | CBK |
| Nov 6, 2002 | K023350 | ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS Respironics California, Inc. | CBK |
| Nov 6, 2002 | K022674 | BIRD AVEA VENTILATOR Bird Products Corp. | CBK |
| Sep 19, 2002 | K022132 | SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E Siemens Medical Solutions USA, Inc. | CBK |
| Aug 13, 2002 | K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION Puritan-Bennett | CBK |
| Aug 1, 2002 | K012693 | MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES Acutronic Medical Systems AG | CBK |
| May 22, 2002 | K013642 | AVEA Bird Products Corp. | CBK |
| Apr 22, 2002 | K020746 | BIRD TBIRD VELA VENTILATOR Bird Products Corp. | CBK |
| Dec 20, 2001 | K010793 | OXYLOG 1000, MODEL 2M86840 Drager Medizintechnik GmbH | CBK |
| Dec 18, 2001 | K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E Siemens Elema AB | CBK |
| Sep 4, 2001 | K012177 | VENTVIEW, MODEL 8414095 Drager Medizintechnik GmbH | CBK |
| Jul 23, 2001 | K010317 | AV 800 VENTILATOR Penlon , Ltd., GB | CBK |
| Jul 18, 2001 | K011957 | IVENT 201 PORTABLE VENTILATOR Versamed , Ltd., IL | CBK |
| Jun 25, 2001 | K003068 | SAVINA Drager Medizintechnik GmbH | CBK |
| Jun 14, 2001 | K010093 | NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 Drager Medizintechnik GmbH | CBK |
| Mar 20, 2001 | K010608 | MODIFICATION TO LAP TOP VENTILATOR (LTV) Pulmonetic Systems, Inc. | CBK |
| Dec 15, 2000 | K003770 | BIRD TBIRD LEGACY VENTILATOR Bird Products Corp. | CBK |
| Dec 8, 2000 | K002951 | MAGELLAN VENTILATOR Oceanic Medical Products, Inc. | CBK |
| Oct 20, 2000 | K001646 | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION Puritan Bennett Corp. | CBK |
| Oct 18, 2000 | K002686 | ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E Nellcor Puritan Bennett, Inc. | CBK |
| Oct 11, 2000 | K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 Pulmonetic Systems, Inc. | CBK |
| Aug 4, 2000 | K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL Newport Medical Instruments, Inc. | CBK |
| Jun 23, 2000 | K001686 | GALILEO VENTILATOR Hamilton Medical, Inc. | CBK |
| May 12, 2000 | K001208 | ESPIRT Respironics, Inc. | CBK |
| Dec 20, 1999 | K993449 | BIRD V.I.P. GOLD/STERLING Bird Products Corp. | CBK |
| Nov 24, 1999 | K993071 | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 Puritan Bennett Corp. | CBK |
| Nov 18, 1999 | K990177 | NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR Nellcor Puritan Bennett, Inc. | CBK |
| Nov 10, 1999 | K993167 | MILLENNIUM INFANT VENTILATOR Sechrist Industries, Inc. | CBK |
| Sep 23, 1999 | K972833 | E100M VENTILATOR (E100M) Newport Medical Instruments, Inc. | CBK |
| Sep 17, 1999 | K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 Instrumentation Industries, Inc. | CBK |
| Sep 16, 1999 | K992788 | BEAR CUB 750 PSV Bear Medical Systems, Inc. | CBK |
| Sep 14, 1999 | K982910 | HAMILTON MEDICAL GALILEOVENTILATOR Hamilton Medical, Inc. | CBK |
| Aug 24, 1999 | K992608 | ATC OPTION FOR EVITA 2 DURA AND EVITA 4 Drager, Inc. | CBK |
| Apr 15, 1999 | K982132 | BLEASE 6200 ANAESTHESIA VENTILATOR Blease Medical Equipment , Ltd. | CBK |
| Apr 12, 1999 | K984056 | LTV 1000 Pulmonetic Systems, Inc. | CBK |
| Apr 7, 1999 | K981668 | SMARTVENT 201 PORTABLE VENTILATOR Versamed , Ltd., IL | CBK |
| Feb 24, 1999 | K990429 | MODIFICATION OF VENTURI VENTILATOR Cardiopulmonary Corp. | CBK |
| Jan 22, 1999 | K984577 | DRAGER OXYLOG 2000 Drager, Inc. | CBK |
| Dec 28, 1998 | K984535 | PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION Puritan Bennett Corp. | CBK |
| Dec 10, 1998 | K984379 | NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM Puritan Bennett Corp., IE | CBK |
| Dec 7, 1998 | K983219 | NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 Drager, Inc. | CBK |
| Nov 23, 1998 | K981412 | M1145 (UPS1-1.25K-1G-MP) UPS Clary Corp. | CBK |
| Nov 20, 1998 | K983981 | BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE Bear Medical Systems, Inc. | CBK |
| Nov 12, 1998 | K981072 | ESPRIT VENTILATOR Respironics, Inc. | CBK |
| Oct 30, 1998 | K981371 | LTV 1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Oct 22, 1998 | K982580 | BIRD MONITOR INTERFACE Bird Products Corp. | CBK |
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