510(k) Report

Devices descending from K895541

137 later devices reach V.I.P. Bird Infant - Pediatric Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993167Millennium Infant VentilatorSechrist Industries, Inc.19991—
+1K992788Bear Cub 750 PSVBear Medical Systems, Inc.1999134—
+2K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation20120—
+2K013642AVEABird Products Corp.2002133Class I
+3K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+3K081837Avea VentilatorCardinal Health 207, Inc.200813—
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+3K022674Bird Avea VentilatorBird Products Corp.2002585
+4K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+4K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+4K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+4K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+4K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+5K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+5K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+5K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+5K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+5K131774Hamilton-G5Hamilton Medical AG201310Class I
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K101643Model LTV 1100 VentilatorCare Fusion20111—
+5K093094Vela VentilatorCardinal Health 207, Inc.20102—
+5K093261MOVESThornhill Research, Inc.20107Class I
+5K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+5K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+5K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+5K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+5K072926Helontix VentLinde Gas Therapeutics20080—
+5K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+5K060705Carina HomeDraeger Medical B.V.2006221
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K180295Hamilton-G5Hamiton Medical AG20192—
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+6K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K153688Edi Catheter ENFitMaquet Critical Care AB201711
+6K160481Vivo 60Breas Medical AB201672
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+6K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+6K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+6K140049Moves SLCThornhill Research, Inc.20141—
+6K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+6K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+6K103211Avea VentilatorCare Fusion20115Class I
+6K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+6K103167Stellar 150Resmed Germany, Inc.201120—
+6K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+6K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+6K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+6K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+7K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K210384Carescape R860Datex-Ohmeda, Inc.20210—
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+7K193228Hamilton-G5Hamilton Medical AG20201—
+7K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+7K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K161420Moves SLCThornhill Research, Inc.20170—
+7K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+7K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+7K122715Stellar 150Resmed Germany, Inc.20130Class I
+7K113640Stellar 150Resmed Germany, Inc.20121—
+7K113288Vpap ST-aResmed, Ltd.20127—
+7K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+7K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+7K112914Vpap TXResmed, Ltd.20110—
+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—
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+8K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+8K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—