510(k) Report

Devices descending from K981371

65 later devices reach LTV 1000 Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101643Model LTV 1100 VentilatorCare Fusion20111—
+1K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+1K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+1K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+1K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+1K040790Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc.200444—
+2K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+2K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class 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—
+2K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+2K062267Oxylog 3000Drager Medical B.V.200620Class I
+2K060705Carina HomeDraeger Medical B.V.2006221
+3K233486731 Series VentilatorZOLL Medical Corporation20240—
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+3K103167Stellar 150Resmed Germany, Inc.201120—
+3K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+3K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V.20083Class I
+3K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K113640Stellar 150Resmed Germany, Inc.20121—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+4K113288Vpap ST-aResmed, Ltd.20127—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K112914Vpap TXResmed, Ltd.20110—
+4K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K233452Vivo 45 LSBreas Medical AB202501
+5K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+5K153061Juno VPAP ST-AResmed, Ltd.20163—
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K123511S9 Vpap TXResmed, Ltd.20131—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K121225Hamilton-C2Hamilton Medical AG20128Class I
+5K122324Vpap S-aResmed, Ltd.20120—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+6K152664TAV SystemNew Aera, Inc.20160—
+6K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+6K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+6K123637Hamilton-C3Hamilton Medical AG20124—
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+7K161450Hamilton-C3Hamilton Medical AG201732
+8K201306Hamilton-C3Hamilton Medical AG20210Class I
+8K201658Hamilton-C6Hamilton Medical AG20201Class I
+9K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—