510(k) Report

Devices descending from K902859

235 later devices reach Servo Ventilator 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+4K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+4K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+4K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+4K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+4K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+4K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+4K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+4K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB20142Class I
+4K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+4K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K103803Hamilton-G5Hamilton Medical AG201114Class I
+4K103167Stellar 150Resmed Germany, Inc.201120—
+4K101643Model LTV 1100 VentilatorCare Fusion20111—
+4K102775Hamilton-C2Hamilton Medical AG201114—
+4K093094Vela VentilatorCardinal Health 207, Inc.20102—
+4K093261MOVESThornhill Research, Inc.20107Class I
+4K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+4K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+4K090468Hamilton-C2Hamilton Medical AG20090—
+4K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+4K081845IVENT101Versamed Medical Systems, Inc.20090—
+4K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+4K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+4K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+4K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett20078Class I
+4K070513Hamilton-G5Hamilton Medical AG2007261
+4K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+4K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006481
+4K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+4K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB200473Class I
+5K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+5K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+5K243765LuMon (TM) SystemSentec AG20250—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K210384Carescape R860Datex-Ohmeda, Inc.20210—
+5K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+5K170872Aisys CS2Datex-Ohmeda, Inc.201704
+5K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB20171—
+5K153688Edi Catheter ENFitMaquet Critical Care AB201711
+5K160481Vivo 60Breas Medical AB201672
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K152068Astral 100/150Resmed, Ltd.20161Class I
+5K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+5K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+5K140049Moves SLCThornhill Research, Inc.20141—
+5K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+5K112754IVENT101Versamed Medical Systems, Ltd.20129—
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K112914Vpap TXResmed, Ltd.20110—
+5K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+5K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+5K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+5K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc.20080—
+5K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+5K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+6K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB20200Class I
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+6K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K161420Moves SLCThornhill Research, Inc.20170—