510(k) Report

Devices descending from K041775

107 later devices reach GE Datex-Ohmeda Engstrom Carestation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.200549—
+1K051767LTV 1000 VentilatorPulmonetic Systems, Inc.200557—
+1K050860GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc.20050—
+1K050597GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20050—
+2K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd.20260—
+2K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+2K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+2K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+2K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett20078Class I
+2K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+2K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006481
+2K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+3K183226Care Orchestrator EssenceRespironics, Inc.20190—
+3K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+3K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+3K133868Astral VentilatorResmed, Ltd.2014102
+3K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K112754IVENT101Versamed Medical Systems, Ltd.20129—
+3K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+3K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+3K101643Model LTV 1100 VentilatorCare Fusion20111—
+3K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+3K093094Vela VentilatorCardinal Health 207, Inc.20102—
+3K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+3K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+3K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+3K081845IVENT101Versamed Medical Systems, Inc.20090—
+3K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc.20080—
+3K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+3K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K080181Modification to Galileo GoldHamilton Medical AG200821—
+3K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+4K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K160481Vivo 60Breas Medical AB201672
+4K152068Astral 100/150Resmed, Ltd.20161Class I
+4K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+4K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+4K103803Hamilton-G5Hamilton Medical AG201114Class I
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+4K102775Hamilton-C2Hamilton Medical AG201114—
+4K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+4K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+4K090468Hamilton-C2Hamilton Medical AG20090—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K172875Astral 100/150Resmed, Ltd.20180Class I
+5K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+5K131774Hamilton-G5Hamilton Medical AG201310Class I
+5K121225Hamilton-C2Hamilton Medical AG20128Class I
+5K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+5K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+5K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+5K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+5K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K180295Hamilton-G5Hamiton Medical AG20192—
+6K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+6K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+6K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+6K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+6K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+6K122438Hamilton-MR1Hamilton Medical AG201311
+6K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+6K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+6K123637Hamilton-C3Hamilton Medical AG20124—
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+7K210384Carescape R860Datex-Ohmeda, Inc.20210—
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K193228Hamilton-G5Hamilton Medical AG20201—
+7K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+7K170872Aisys CS2Datex-Ohmeda, Inc.201704
+7K153046Hamilton-MR1Hamilton Medical AG20160Class I
+7K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+7K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+7K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+7K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+8K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—