510(k) Report

Devices descending from K061627

86 later devices reach Modification to I Vent 201 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+1K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+1K081845IVENT101Versamed Medical Systems, Inc.20090—
+1K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+1K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+1K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+1K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+2K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+2K181166Trilogy EvoRespironics, Inc.20195Class I
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+2K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+2K122715Stellar 150Resmed Germany, Inc.20130Class I
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+2K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+2K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+2K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+2K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+2K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+2K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+2K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+3K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+3K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+3K160481Vivo 60Breas Medical AB201672
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+3K131774Hamilton-G5Hamilton Medical AG201310Class I
+3K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+3K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+3K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+3K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+4K233452Vivo 45 LSBreas Medical AB202501
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K180295Hamilton-G5Hamiton Medical AG20192—
+4K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class 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—
+4K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+4K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+4K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+4K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+4K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+4K103211Avea VentilatorCare Fusion20115Class I
+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
+5K193228Hamilton-G5Hamilton Medical AG20201—
+5K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+5K170872Aisys CS2Datex-Ohmeda, Inc.201704
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+5K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+5K122438Hamilton-MR1Hamilton Medical AG201311
+5K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+5K123637Hamilton-C3Hamilton Medical AG20124—
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+6K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+6K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+6K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+6K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+6K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+6K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+7K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+7K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+7K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+7K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+8K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—