510(k) Report

Devices descending from K981668

136 later devices reach Smartvent 201 Portable Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+1K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+1K032386Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc.20048—
+1K011957Ivent 201 Portable VentilatorVersamed, Ltd.2001134—
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+2K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+2K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+2K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+2K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+2K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2004123—
+3K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+3K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+3K133868Astral VentilatorResmed, Ltd.2014102
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K101643Model LTV 1100 VentilatorCare Fusion20111—
+3K093094Vela VentilatorCardinal Health 207, Inc.20102—
+3K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+3K081845IVENT101Versamed Medical Systems, Inc.20090—
+3K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+3K062267Oxylog 3000Drager Medical B.V.200620Class I
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K160481Vivo 60Breas Medical AB201672
+4K152068Astral 100/150Resmed, Ltd.20161Class I
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+4K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+4K093261MOVESThornhill Research, Inc.20107Class I
+4K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V.20083Class I
+4K060705Carina HomeDraeger Medical B.V.2006221
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K172875Astral 100/150Resmed, Ltd.20180Class I
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+5K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+5K140049Moves SLCThornhill Research, Inc.20141—
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+5K103167Stellar 150Resmed Germany, Inc.201120—
+5K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+5K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+6K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+6K161420Moves SLCThornhill Research, Inc.20170—
+6K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+6K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+6K122438Hamilton-MR1Hamilton Medical AG201311
+6K121225Hamilton-C2Hamilton Medical AG20128Class I
+6K113640Stellar 150Resmed Germany, Inc.20121—
+6K113288Vpap ST-aResmed, Ltd.20127—
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+6K112914Vpap TXResmed, Ltd.20110—
+6K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+6K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+6K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+7K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+7K153061Juno VPAP ST-AResmed, Ltd.20163—
+7K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+7K122715Stellar 150Resmed Germany, Inc.20130Class I
+7K123511S9 Vpap TXResmed, Ltd.20131—
+7K123637Hamilton-C3Hamilton Medical AG20124—
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K122324Vpap S-aResmed, Ltd.20120—
+7K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+7K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+7K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+7K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+8K213169BPAP SystemBMC Medical Co., Ltd.20220—
+8K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+8K161450Hamilton-C3Hamilton Medical AG201732
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+8K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+8K131774Hamilton-G5Hamilton Medical AG201310Class I
+8K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+8K103803Hamilton-G5Hamilton Medical AG201114Class I
+8K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+8K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+8K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+9K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—