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 |
|---|---|---|---|
| Sep 6, 2016 | K153046 | HAMILTON-MR1 Hamilton Medical AG, CH | CBK |
| May 13, 2016 | K152068 | Astral 100/150 Resmed, Ltd., AU | CBK |
| Mar 30, 2016 | K143035 | Flight 60 Ventilator Flight Medical Innovations , Ltd., IL | CBK |
| Mar 29, 2016 | K151252 | Puritan Bennett 840 Series Ventilator System Covidien LP | CBK |
| Dec 21, 2015 | K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System Maquet Critical Care AB, SE | CBK |
| Nov 5, 2015 | K151901 | AirView Resmed, Ltd., AU | CBK |
| Sep 18, 2015 | K150638 | AF541 SE Full Face Mask Respironics, Inc. | CBK |
| Sep 2, 2015 | K140939 | HAMILTON-T1,HAMILTON-C1 Hamilton Medical AG, CH | CBK |
| Jun 12, 2015 | K142679 | CARESCAPE R860 Datex-Ohmeda, Inc. | CBK |
| Jun 12, 2015 | K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM Breathe Technologies | CBK |
| Feb 3, 2015 | K140575 | ENGSTROM CARESTATION, ENGSTROM PRO Datex-Ohmeda, Inc. | CBK |
| Aug 8, 2014 | K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS Draeger Medical GmbH | CBK |
| Jun 20, 2014 | K123149 | SERVO-I VENTILATOR SYSTEM Maquet Critical Care AB | CBK |
| Jun 4, 2014 | K133868 | ASTRAL VENTILATOR Resmed, Ltd. | CBK |
| Apr 8, 2014 | K130171 | FLIGHT 60 VENTILATOR Flight Medical Innovations , Ltd. | CBK |
| Feb 24, 2014 | K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM Covidien | CBK |
| Nov 20, 2013 | K122438 | HAMILTON-MR1 Hamilton Medical AG, CH | CBK |
| Oct 29, 2013 | K130178 | INSPIRATION VENTILATOR SYSTEM 5I/7I eVent Medical, Ltd. | CBK |
| Oct 9, 2013 | K131774 | HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Jun 6, 2013 | K120931 | CRITICAL CARE VENTILATOR Oricare, Inc. | CBK |
| Mar 26, 2013 | K122560 | VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 Pan-America Hyperbarics, Inc. | CBK |
| Dec 21, 2012 | K123637 | HAMILTON-C3 Hamilton Medical AG, CH | CBK |
| Dec 18, 2012 | K113743 | EVOLUTION 3E VENTILATOR Event Medical, Inc. | CBK |
| Dec 11, 2012 | K120146 | QUARK SERIES Cosmed Srl | CBK |
| Nov 16, 2012 | K121225 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Nov 9, 2012 | K121891 | NEWPORT AURA VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Oct 11, 2012 | K121379 | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY Airon Corporation | CBK |
| Jul 10, 2012 | K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK Respironics, Inc. | CBK |
| Jul 6, 2012 | K120726 | FLIGHT 60 VENTILATOR Flight Medical Innovations , Ltd. | CBK |
| Jun 15, 2012 | K112754 | IVENT101 Versamed Medical Systems , Ltd., IL | CBK |
| Jun 11, 2012 | K112729 | BLEASE700/900 SERIES VENTILATORS Spacelabs Healthcare | CBK |
| May 30, 2012 | K120574 | HAMILTON-C1 Hamilton Medical AG, CH | CBK |
| Apr 3, 2012 | K120670 | HAMILTON-T1 Hamilton Medical AG, CH | CBK |
| Mar 22, 2012 | K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare | CBK |
| Feb 16, 2012 | K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc. | CBK |
| Feb 9, 2012 | K112006 | HAMILTON-TC1 Hamilton Medical AG, CH | CBK |
| Jan 27, 2012 | K111595 | NEUMOVENT GRAPHNET Tecme S.A. | CBK |
| Jan 13, 2012 | K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE Respironics California, Inc. | CBK |
| Dec 1, 2011 | K111146 | NEWPORT HT70 VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Nov 23, 2011 | K103803 | HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Oct 31, 2011 | K111683 | FLIGHT 60 VENTILATOR Flight Medical Innovations , Ltd. | CBK |
| Oct 14, 2011 | K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY Respironics, Inc. | CBK |
| Oct 6, 2011 | K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE Draeger Medical Systems, Inc. | CBK |
| Sep 9, 2011 | K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 Datex-Ohmeda | CBK |
| Aug 19, 2011 | K110795 | V200 INTELLI-TRAK OPTION Respironics California, Inc. | CBK |
| Aug 12, 2011 | K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 Hsiner Co., Ltd. | CBK |
| May 12, 2011 | K103211 | AVEA VENTILATOR Care Fusion | CBK |
| Apr 7, 2011 | K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc. | CBK |
| Mar 2, 2011 | K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION Spacelabs Healthcare, Ltd. | CBK |
| Jan 26, 2011 | K101643 | MODEL LTV 1100 VENTILATOR Care Fusion | CBK |
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