510(k) Report

Devices descending from K073706

47 later devices reach Respiratory Humidifier, Model MR850 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222351inspired™ VHB20 Heated HumidifierVincent Healthcare Products Limited20220—
+1K161314Flexicare FL-9000U Respiratory Humidifier BaseFlexicare Medical Limited.20161—
+1K132017HC550 Respiratory Humidifier, Adult Ventilator CircuitFisher & Paykel Healthcare, Ltd.20140—
+1K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+1K122705Humicare D900Grundler GmbH20131—
+1K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+1K110019Respiratory HumidiferFisher & Paykel Healthcare, Ltd.20122—
+1K102618Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG20102—
+1K092256Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Smiths Medical Asd, Inc.20102—
+1K100554Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441Fisher & Paykel Healthcare, Ltd.20104—
+1K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+2K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.20260—
+2K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+2K233707HFT150Invent Medical Corporation20240—
+2K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+2K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+2K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+2K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa20231—
+2K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+2K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+2K180474TNI softFlow 50Tni Medical AG20180—
+2K133766Humicare D900Gruendler GmbH20140—
+2K131957MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual…Fisher & Paykel Healthcare, Ltd.20133—
+2K103316FlowrestVapotherm, Inc.20113—
+3K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+3K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+3K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+3K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+3K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+3K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+3K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+3K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+3K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+3K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+3K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+3K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitFisher & Paykel Healthcare, Ltd.20151—
+3K141940Conchasmart ColumnTeleflex, Inc.20140—
+4K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+4K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+4K242931HFT750UMekics Co., Ltd.20250—
+4K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+4K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+4K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+4K223684F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd.20230—
+4K203357HVT 2.0Vapotherm, Inc.20211—
+5K254078HVT 2.0Vapotherm, Inc.20260—
+5K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—