510(k) Report

Devices descending from K970839

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+5K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+5K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+5K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+5K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+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
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K103211Avea VentilatorCare Fusion20115Class I
+5K101643Model LTV 1100 VentilatorCare Fusion20111—
+5K093094Vela VentilatorCardinal Health 207, Inc.20102—
+5K093261MOVESThornhill Research, Inc.20107Class I
+5K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+5K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+5K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+5K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+5K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+6K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+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
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+6K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB20200Class I
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+6K170872Aisys CS2Datex-Ohmeda, Inc.201704
+6K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+6K160481Vivo 60Breas Medical AB201672
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+6K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+6K140049Moves SLCThornhill Research, Inc.20141—
+6K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+6K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+6K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+6K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+6K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+7K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+7K161420Moves SLCThornhill Research, Inc.20170—
+7K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+7K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+7K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+7K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+8K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+8K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+8K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+8K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+8K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+8K122438Hamilton-MR1Hamilton Medical AG201311
+9K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—