510(k) Report

Devices descending from K950484

162 later devices reach Tbird VS Ventilator and Tbird Avs Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020746Bird Tbird Vela VentilatorBird Products Corp.2002120—
+1K981668Smartvent 201 Portable VentilatorVersamed, Ltd.1999136—
+1K981371LTV 1000 VentilatorPulmonetic Systems, Inc.19986512
+1K981971Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with…Bird Products Corp.199842—
+1K972248Nellcor Puritan Bennett GeminiNellcor Puritan Bennett, Inc.19970—
+2K101643Model LTV 1100 VentilatorCare Fusion20111—
+2K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+2K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+2K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+2K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+2K040790Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc.200444—
+2K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa200415—
+2K040540Modification to LTV 1000 VentilatorPulmonetic Systems, Inc.2004108
+2K032386Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc.20048—
+2K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+2K011957Ivent 201 Portable VentilatorVersamed, Ltd.2001134—
+2K984056LTV 1000Pulmonetic Systems, Inc.19994012
+3K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+3K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+3K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+3K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+3K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+3K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+3K062267Oxylog 3000Drager Medical B.V.200620Class I
+3K060705Carina HomeDraeger Medical B.V.2006221
+3K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K053270IVENT 201Versamed Medical Systems, Inc.200687—
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2004123—
+3K034032PLV Continuum Ventilator, Model P2000Respironics California, Inc.20041—
+3K022750PLV Continuum Ventilator, Model P1000Respironics California, Inc.2003292
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K183226Care Orchestrator EssenceRespironics, Inc.20190—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+4K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K112754IVENT101Versamed Medical Systems, Ltd.20129—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+4K103167Stellar 150Resmed Germany, Inc.201120—
+4K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+4K093094Vela VentilatorCardinal Health 207, Inc.20102—
+4K093261MOVESThornhill Research, Inc.20107Class I
+4K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+4K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+4K081845IVENT101Versamed Medical Systems, Inc.20090—
+4K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V.20083Class I
+4K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+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
+5K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+5K160481Vivo 60Breas Medical AB201672
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K152068Astral 100/150Resmed, Ltd.20161Class I
+5K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+5K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+5K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+5K140049Moves SLCThornhill Research, Inc.20141—
+5K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+5K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K112914Vpap TXResmed, Ltd.20110—
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+5K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+5K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+6K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K161420Moves SLCThornhill Research, Inc.20170—
+6K161450Hamilton-C3Hamilton Medical AG201732