510(k) Report

Devices descending from K902506

251 later devices reach 7200AE Microprocessor Ventilator W/Enhanced Hard. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc.20022Class I
+1K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option…Puritan Bennett Corp.19990Class I
+1K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp.199855Class I
+1K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp.199884
+1K983112Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd.1998735
+1K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp.1998174Class I
+1K964540Nellcor Puritan Bennett, 740 Ventilator SystemPuritan Bennett Corp.199794
+2K223684F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd.20230—
+2K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical20170—
+2K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG20161—
+2K122705Humicare D900Grundler GmbH20131—
+2K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+2K102618Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG20102—
+2K072926Helontix VentLinde Gas Therapeutics20080—
+2K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp.20070—
+2K062093Avea VentilatorViasys Respiratory Care, Inc.2006215
+2K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+2K040574Galileo GoldHamilton Medical, Inc.200453—
+2K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+2K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+2K022679RaphaelHamilton Medical AG2003543
+2K020332Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd.2003651
+2K021112Inspiration Ventilator SystemeVent Medical, Ltd.20026—
+2K013642AVEABird Products Corp.2002133Class I
+2K993773Humid-HeatHudson Rcj AB20000—
+2K993268Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L.20000—
+3K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+3K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa20231—
+3K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG201701
+3K151303AirLife Infant Heated Wire CircuitCare Fusion20160Class I
+3K133766Humicare D900Gruendler GmbH20140—
+3K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+3K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K081837Avea VentilatorCardinal Health 207, Inc.200813—
+3K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K061090Galileo Gold AsvHamilton Medical AG200636—
+3K052863Raphael ColorHamilton Medical AG200613
+3K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+3K051262Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc.200501
+3K034026RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd.200512—
+3K033710MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd.200454—
+3K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+3K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.20044—
+3K022674Bird Avea VentilatorBird Products Corp.2002585
+4K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+4K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+4K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+4K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+4K231380AirLife DuoTherm™ Humidification SystemVyaire Medical, Inc.20230—
+4K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+4K160540Flexicare Neonatal Heated Wire Breathing SystemFlexicare Medical Limited.20160—
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K103767Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd.201210—
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+4K102775Hamilton-C2Hamilton Medical AG201114—
+4K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+4K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+4K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+4K090468Hamilton-C2Hamilton Medical AG20090—
+4K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+4K080181Modification to Galileo GoldHamilton Medical AG200821—
+4K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+4K073706Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd.200847—
+4K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+4K072982Pari Hydrate VPari Innovative Manufacturers, Inc.20070—
+4K070513Hamilton-G5Hamilton Medical AG2007261
+4K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+4K063758Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier…Teleflex Medical200722
+4K061736Comfort Flo Humidification System and Nasal CannulaTeleflex Medical20062—
+4K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+4K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+4K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+4K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+5K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit…Vincent Healthcare Products Limited20260—
+5K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+5K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+5K222897Enlight 2100Timpel S.A.20232—
+5K222351inspired™ VHB20 Heated HumidifierVincent Healthcare Products Limited20220—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+5K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.20180Class I
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K161314Flexicare FL-9000U Respiratory Humidifier BaseFlexicare Medical Limited.20161—
+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