510(k) Report

Devices descending from K013642

133 later devices reach AVEA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+1K081837Avea VentilatorCardinal Health 207, Inc.200813—
+1K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+1K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+1K022674Bird Avea VentilatorBird Products Corp.2002585
+2K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+2K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+2K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+2K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+2K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+2K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+2K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+2K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+2K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+2K053270IVENT 201Versamed Medical Systems, Inc.200687—
+2K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+2K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+3K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+3K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+3K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+3K133868Astral VentilatorResmed, Ltd.2014102
+3K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+3K131774Hamilton-G5Hamilton Medical AG201310Class I
+3K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+3K101643Model LTV 1100 VentilatorCare Fusion20111—
+3K093094Vela VentilatorCardinal Health 207, Inc.20102—
+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
+3K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+3K081845IVENT101Versamed Medical Systems, Inc.20090—
+3K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+3K072926Helontix VentLinde Gas Therapeutics20080—
+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—
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K180295Hamilton-G5Hamiton Medical AG20192—
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+4K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+4K161450Hamilton-C3Hamilton Medical AG201732
+4K153688Edi Catheter ENFitMaquet Critical Care AB201711
+4K160481Vivo 60Breas Medical AB201672
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K152068Astral 100/150Resmed, Ltd.20161Class I
+4K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+4K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+4K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+4K140049Moves SLCThornhill Research, Inc.20141—
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K103211Avea VentilatorCare Fusion20115Class 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—
+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—
+5K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K210384Carescape R860Datex-Ohmeda, Inc.20210—
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+5K193228Hamilton-G5Hamilton Medical AG20201—
+5K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+5K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+5K172875Astral 100/150Resmed, Ltd.20180Class I
+5K161420Moves SLCThornhill Research, Inc.20170—
+5K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+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—
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+6K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+6K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+6K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+6K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I