510(k) Report

Devices descending from K020746

120 later devices reach Bird Tbird Vela Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa200415—
+1K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+2K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+2K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+2K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+2K102775Hamilton-C2Hamilton Medical AG201114—
+2K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+2K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+2K053270IVENT 201Versamed Medical Systems, Inc.200687—
+2K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+3K093261MOVESThornhill Research, Inc.20107Class I
+3K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+3K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+3K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+3K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+3K060705Carina HomeDraeger Medical B.V.2006221
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+4K140049Moves SLCThornhill Research, Inc.20141—
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+4K103167Stellar 150Resmed Germany, Inc.201120—
+4K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+4K081845IVENT101Versamed Medical Systems, Inc.20090—
+4K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+4K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+4K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+5K161420Moves SLCThornhill Research, Inc.20170—
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K112914Vpap TXResmed, Ltd.20110—
+5K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+5K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+5K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+5K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+6K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+6K160481Vivo 60Breas Medical AB201672
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+6K122438Hamilton-MR1Hamilton Medical AG201311
+6K131774Hamilton-G5Hamilton Medical AG201310Class I
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+6K122324Vpap S-aResmed, Ltd.20120—
+6K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+6K103803Hamilton-G5Hamilton Medical AG201114Class I
+6K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K180295Hamilton-G5Hamiton Medical AG20192—
+7K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+7K153688Edi Catheter ENFitMaquet Critical Care AB201711
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+7K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+7K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+7K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+7K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+7K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+7K103211Avea VentilatorCare Fusion20115Class I
+8K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—