510(k) Report

Devices descending from K980642

112 later devices reach EVITA 4 (8411900) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+1K083050Evite XLDraeger Medical AG & Co. KG20082—
+1K072450Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc.20076—
+1K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+1K040574Galileo GoldHamilton Medical, Inc.200453—
+1K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB2004751
+1K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc.2002102—
+2K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+2K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+2K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+2K121225Hamilton-C2Hamilton Medical AG20128Class I
+2K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+2K093094Vela VentilatorCardinal Health 207, Inc.20102—
+2K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+2K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+2K073069Modification to Avea VentilatorViasys Respiratory Care, Inc.20083Class I
+2K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+2K061090Galileo Gold AsvHamilton Medical AG200636—
+2K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+2K052863Raphael ColorHamilton Medical AG200613
+2K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB200473Class I
+2K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+2K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.20044—
+3K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+3K222897Enlight 2100Timpel S.A.20232—
+3K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+3K123637Hamilton-C3Hamilton Medical AG20124—
+3K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K101643Model LTV 1100 VentilatorCare Fusion20111—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+3K072926Helontix VentLinde Gas Therapeutics20080—
+3K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+3K080181Modification to Galileo GoldHamilton Medical AG200821—
+3K070513Hamilton-G5Hamilton Medical AG2007261
+3K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+3K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+3K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+3K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+4K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+4K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+4K243765LuMon (TM) SystemSentec AG20250—
+4K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K161450Hamilton-C3Hamilton Medical AG201732
+4K153688Edi Catheter ENFitMaquet Critical Care AB201711
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+4K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+4K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+4K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+4K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+4K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+4K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+4K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+4K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+5K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+5K210384Carescape R860Datex-Ohmeda, Inc.20210—
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+5K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+5K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+5K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+5K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+5K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+5K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+5K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K103211Avea VentilatorCare Fusion20115Class I
+5K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+5K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+6K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+6K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K170872Aisys CS2Datex-Ohmeda, Inc.201704
+6K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+6K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+6K131790A9800 Anesthesia WorkstationOricare, Inc.20140—