510(k) Report

Devices descending from K023366

134 later devices reach Datex-Ohmeda 7900 Ventilator Enhancements through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+1K051222AV-S Anaesthesia VentilatorPenlon Limited20050—
+1K050626GE Datex-Ohmeda Aespire 7900 Anesthesia SystemDatex-Ohmeda, Inc.200541
+1K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2004107—
+1K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20041Class I
+1K042086Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20042—
+1K040743Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc.200438—
+2K092864Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C20103—
+2K072884Fabius MriDraeger Medical AG & Co. KG20080Class I
+2K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda200733—
+2K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.200549—
+2K051767LTV 1000 VentilatorPulmonetic Systems, Inc.200557—
+2K050860GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc.20050—
+2K050597GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20050—
+2K042154GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc.2004363
+3K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd.20260—
+3K122445Aespire 7900, Aespire ViewDatex-Ohmeda20122Class I
+3K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+3K090892GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy200901
+3K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+3K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+3K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.2008304
+3K080175Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division2008112
+3K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett20078Class I
+3K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+3K061609GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.2006341
+3K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006481
+3K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K050676GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)Datex-Ohmeda, Inc.200513
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+4K183226Care Orchestrator EssenceRespironics, Inc.20190—
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+4K143530Aespire ViewDatex-Ohmeda, Inc.201511
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112754IVENT101Versamed Medical Systems, Ltd.20129—
+4K120075AM-6000 Anesthesia MachineAdvanced Instrumentations, Inc.20120—
+4K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc.20119Class I
+4K101643Model LTV 1100 VentilatorCare Fusion20111—
+4K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+4K093094Vela VentilatorCardinal Health 207, Inc.20102—
+4K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+4K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+4K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+4K081845IVENT101Versamed Medical Systems, Inc.20090—
+4K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.2009192
+4K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc.20080—
+4K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+4K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+4K080181Modification to Galileo GoldHamilton Medical AG200821—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K160481Vivo 60Breas Medical AB201672
+5K152068Astral 100/150Resmed, Ltd.20161Class I
+5K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+5K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division201381
+5K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+5K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+5K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB20123Class I
+5K103803Hamilton-G5Hamilton Medical AG201114Class I
+5K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+5K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+5K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB20114—
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K102775Hamilton-C2Hamilton Medical AG201114—
+5K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+5K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+5K090468Hamilton-C2Hamilton Medical AG20090—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K171311A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+6K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+6K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+6K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB20142Class I
+6K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+6K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+6K131774Hamilton-G5Hamilton Medical AG201310Class I
+6K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+6K121225Hamilton-C2Hamilton Medical AG20128Class I
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I