510(k) Report

Devices descending from K913367

75 later devices reach Models MR410 & MR480 Respiratory Humidifier/Access through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K953392HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd.199674—
+2K131957MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual…Fisher & Paykel Healthcare, Ltd.20133—
+2K983112Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd.1998735
+3K223684F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd.20230—
+3K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical20170—
+3K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG20161—
+3K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitFisher & Paykel Healthcare, Ltd.20151—
+3K141940Conchasmart ColumnTeleflex, Inc.20140—
+3K122705Humicare D900Grundler GmbH20131—
+3K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+3K102618Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG20102—
+3K020332Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd.2003651
+3K993773Humid-HeatHudson Rcj AB20000—
+3K993268Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L.20000—
+4K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+4K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa20231—
+4K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG201701
+4K151303AirLife Infant Heated Wire CircuitCare Fusion20160Class I
+4K133766Humicare D900Gruendler GmbH20140—
+4K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+4K034026RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd.200512—
+4K033710MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd.200454—
+5K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+5K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+5K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+5K231380AirLife DuoTherm™ Humidification SystemVyaire Medical, Inc.20230—
+5K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+5K160540Flexicare Neonatal Heated Wire Breathing SystemFlexicare Medical Limited.20160—
+5K103767Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd.201210—
+5K073706Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd.200847—
+5K072982Pari Hydrate VPari Innovative Manufacturers, Inc.20070—
+5K063758Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier…Teleflex Medical200722
+5K061736Comfort Flo Humidification System and Nasal CannulaTeleflex Medical20062—
+6K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit…Vincent Healthcare Products Limited20260—
+6K222351inspired™ VHB20 Heated HumidifierVincent Healthcare Products Limited20220—
+6K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.20180Class I
+6K161314Flexicare FL-9000U Respiratory Humidifier BaseFlexicare Medical Limited.20161—
+6K132017HC550 Respiratory Humidifier, Adult Ventilator CircuitFisher & Paykel Healthcare, Ltd.20140—
+6K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Teleflex, Inc.20141Class I
+6K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+6K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+6K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd.20126—
+6K110019Respiratory HumidiferFisher & Paykel Healthcare, Ltd.20122—
+6K092256Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Smiths Medical Asd, Inc.20102—
+6K100554Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441Fisher & Paykel Healthcare, Ltd.20104—
+6K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+7K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.20260—
+7K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+7K233707HFT150Invent Medical Corporation20240—
+7K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+7K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+7K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+7K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+7K180474TNI softFlow 50Tni Medical AG20180—
+7K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.20170Class I
+7K150900Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.20150—
+7K103316FlowrestVapotherm, Inc.20113—
+8K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+8K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+8K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+8K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+8K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+8K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+8K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+8K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+8K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+9K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+9K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+9K242931HFT750UMekics Co., Ltd.20250—
+9K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+9K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+9K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+9K203357HVT 2.0Vapotherm, Inc.20211—
+10K254078HVT 2.0Vapotherm, Inc.20260—
+10K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—