510(k) Report

Devices descending from K040941

98 later devices reach Cpap Humidifier, Model HC234 (and Related Accessories) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K081029Sleepstyle 200 Auto Series HC254Fisher & Paykel Healthcare, Ltd.20084—
+1K050904Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd.200525—
+1K041900HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd.200474—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+2K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+2K094040F&P Icon Series CpapFisher & Paykel Healthcare, Ltd.201011
+2K100104Hybernite Rainout Control SystemPlastiflex Group NV20106—
+2K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+2K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+2K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+3K173193F&P SleepStyleFisher & Paykel Healthcare, Ltd.20180—
+3K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+3K122705Humicare D900Grundler GmbH20131—
+3K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+3K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+3K1122713B Willow3B Products, LLC201211
+3K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+3K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+3K103316FlowrestVapotherm, Inc.20113—
+3K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+3K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+3K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+4K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+4K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+4K133766Humicare D900Gruendler GmbH20140—
+4K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+4K140124S9 EloueraResmed Corp20148—
+4K132606S9 Cronulla for HerResmed, Ltd.20140—
+4K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+4K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+4K123511S9 Vpap TXResmed, Ltd.20131—
+4K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+4K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+4K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+4K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+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
+5K203357HVT 2.0Vapotherm, Inc.20211—
+5K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+5K203126S10 KirraResmed Pty, Ltd.20200—
+5K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+5K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+5K180474TNI softFlow 50Tni Medical AG20180—
+5K160836Menai SystemResmed, Ltd.20166—
+5K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+5K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K140159S9 Wanda Vpap STResmed, Ltd.20142—
+5K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+5K113801Vpap AdaptResmed Corp20125—
+5K113288Vpap ST-aResmed, Ltd.20127—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+6K254078HVT 2.0Vapotherm, Inc.20260—
+6K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+6K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+6K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+6K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+6K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+6K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+6K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+6K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+6K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+6K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+6K200565GalapogosResmed Corp20213—
+6K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+6K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+6K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K140279S9 GreenhillsResmed, Ltd.20142—
+6K122324Vpap S-aResmed, Ltd.20120—
+7K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+7K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+7K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+7K242931HFT750UMekics Co., Ltd.20250—
+7K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+7K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+7K241216myAirResmed Corp20242—
+7K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+7K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+7K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+8K250624myAirResmed Corp20251—
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—