510(k) Report

Devices descending from K970165

140 later devices reach Evita 2 Dura through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050860GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc.20050—
+1K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2004107—
+1K022679RaphaelHamilton Medical AG2003543
+1K021573Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionPuritan-Bennett200252—
+1K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc.199911—
+2K133886Perseus A500Draeger Medical GmbH20142Class I
+2K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+2K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.200549—
+2K051767LTV 1000 VentilatorPulmonetic Systems, Inc.200557—
+2K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+2K050597GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20050—
+2K042607Primus USDraeger Medical, Inc.2004102
+2K040574Galileo GoldHamilton Medical, Inc.200453—
+3K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd.20260—
+3K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+3K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+3K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+3K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+3K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+3K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+3K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+3K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+3K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+3K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+3K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+3K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett20078Class I
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+3K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+3K061090Galileo Gold AsvHamilton Medical AG200636—
+3K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006481
+3K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K052863Raphael ColorHamilton Medical AG200613
+4K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+4K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+4K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+4K222897Enlight 2100Timpel S.A.20232—
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+4K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+4K183226Care Orchestrator EssenceRespironics, Inc.20190—
+4K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112754IVENT101Versamed Medical Systems, Ltd.20129—
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K103803Hamilton-G5Hamilton Medical AG201114Class I
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K101643Model LTV 1100 VentilatorCare Fusion20111—
+4K102775Hamilton-C2Hamilton Medical AG201114—
+4K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+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—
+4K090468Hamilton-C2Hamilton Medical AG20090—
+4K081845IVENT101Versamed Medical Systems, Inc.20090—
+4K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc.20080—
+4K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+4K080181Modification to Galileo GoldHamilton Medical AG200821—
+4K070513Hamilton-G5Hamilton Medical AG2007261
+4K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+5K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+5K243765LuMon (TM) SystemSentec AG20250—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+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—
+5K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+5K131774Hamilton-G5Hamilton Medical AG201310Class I
+5K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K123637Hamilton-C3Hamilton Medical AG20124—
+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—
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+5K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+5K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+5K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+5K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+6K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—