510(k) Report

Devices descending from K000697

119 later devices reach Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153234AirLife Adult Heated Wire CircuitCarefusion, Inc.20160—
+1K151303AirLife Infant Heated Wire CircuitCare Fusion20160Class I
+1K151959AirLife Infant Single Limb Heated Wire CircuitCarefusion, Inc.20160—
+1K092256Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Smiths Medical Asd, Inc.20102—
+1K071958Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator…Smiths Medical Asd, Inc.20078—
+1K040790Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc.200444—
+1K020332Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd.2003651
+2K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+2K122705Humicare D900Grundler GmbH20131—
+2K102618Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG20102—
+2K100104Hybernite Rainout Control SystemPlastiflex Group NV20106—
+2K062267Oxylog 3000Drager Medical B.V.200620Class I
+2K060705Carina HomeDraeger Medical B.V.2006221
+2K034026RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd.200512—
+2K033710MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd.200454—
+3K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+3K231380AirLife DuoTherm™ Humidification SystemVyaire Medical, Inc.20230—
+3K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa20231—
+3K160540Flexicare Neonatal Heated Wire Breathing SystemFlexicare Medical Limited.20160—
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+3K133766Humicare D900Gruendler GmbH20140—
+3K103767Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd.201210—
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+3K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+3K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+3K103167Stellar 150Resmed Germany, Inc.201120—
+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
+3K073706Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd.200847—
+3K072982Pari Hydrate VPari Innovative Manufacturers, Inc.20070—
+3K063758Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier…Teleflex Medical200722
+3K061736Comfort Flo Humidification System and Nasal CannulaTeleflex Medical20062—
+4K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit…Vincent Healthcare Products Limited20260—
+4K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+4K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—
+4K222351inspired™ VHB20 Heated HumidifierVincent Healthcare Products Limited20220—
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.20180Class I
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K161314Flexicare FL-9000U Respiratory Humidifier BaseFlexicare Medical Limited.20161—
+4K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG20161—
+4K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+4K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+4K132017HC550 Respiratory Humidifier, Adult Ventilator CircuitFisher & Paykel Healthcare, Ltd.20140—
+4K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Teleflex, Inc.20141Class I
+4K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+4K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+4K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd.20126—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K113640Stellar 150Resmed Germany, Inc.20121—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+4K110019Respiratory HumidiferFisher & Paykel Healthcare, Ltd.20122—
+4K113288Vpap ST-aResmed, Ltd.20127—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K112914Vpap TXResmed, Ltd.20110—
+4K100554Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441Fisher & Paykel Healthcare, Ltd.20104—
+4K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.20260—
+5K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+5K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+5K233707HFT150Invent Medical Corporation20240—
+5K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+5K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+5K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+5K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+5K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+5K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+5K180474TNI softFlow 50Tni Medical AG20180—
+5K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG201701
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.20170Class I
+5K153061Juno VPAP ST-AResmed, Ltd.20163—
+5K150900Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.20150—
+5K131957MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual…Fisher & Paykel Healthcare, Ltd.20133—
+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—
+5K103316FlowrestVapotherm, Inc.20113—
+6K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+6K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+6K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+6K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+6K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+6K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+6K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+6K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+6K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitFisher & Paykel Healthcare, Ltd.20151—
+6K141940Conchasmart ColumnTeleflex, Inc.20140—
+6K123637Hamilton-C3Hamilton Medical AG20124—
+7K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—