510(k) Report

Devices descending from K041900

74 later devices reach HC604 Cpap Humidifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094040F&P Icon Series CpapFisher & Paykel Healthcare, Ltd.201011
+1K100104Hybernite Rainout Control SystemPlastiflex Group NV20106—
+1K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+1K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+2K173193F&P SleepStyleFisher & Paykel Healthcare, Ltd.20180—
+2K122705Humicare D900Grundler GmbH20131—
+2K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+2K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+2K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+2K103316FlowrestVapotherm, Inc.20113—
+2K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+3K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+3K133766Humicare D900Gruendler GmbH20140—
+3K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+3K140124S9 EloueraResmed Corp20148—
+3K132606S9 Cronulla for HerResmed, Ltd.20140—
+3K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+3K123511S9 Vpap TXResmed, Ltd.20131—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+3K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+4K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+4K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+4K233707HFT150Invent Medical Corporation20240—
+4K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+4K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+4K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+4K203357HVT 2.0Vapotherm, Inc.20211—
+4K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+4K180474TNI softFlow 50Tni Medical AG20180—
+4K160836Menai SystemResmed, Ltd.20166—
+4K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+4K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+4K140159S9 Wanda Vpap STResmed, Ltd.20142—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K113801Vpap AdaptResmed Corp20125—
+4K113288Vpap ST-aResmed, Ltd.20127—
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K254078HVT 2.0Vapotherm, Inc.20260—
+5K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+5K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+5K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+5K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+5K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+5K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+5K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+5K200565GalapogosResmed Corp20213—
+5K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+5K153061Juno VPAP ST-AResmed, Ltd.20163—
+5K140279S9 GreenhillsResmed, Ltd.20142—
+5K122324Vpap S-aResmed, Ltd.20120—
+6K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+6K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+6K242931HFT750UMekics Co., Ltd.20250—
+6K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+6K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+6K241216myAirResmed Corp20242—
+6K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+6K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+7K250624myAirResmed Corp20251—
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—