510(k) Report

Devices descending from K971260

138 later devices reach Sullivan Humidaire Heated Humidifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013843Autoset Spirit Cpap SystemResmed Corp2002125—
+1K013909S7 Elite CP AP SystemResmed Corp2002128—
+2K121374ZI BlowerDeshum Medical20131—
+2K080797Humidaire 2IResmed, Ltd.20082—
+2K072009Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340Weinmann Gerate Fur Medizin GmbH + Co. KG20070—
+2K071163Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603Weinmann Gerate Fur Medizin GmbH + Co. KG20071—
+2K071171Vpap Auto with H3IResmed, Ltd.200740—
+2K062291Vpap Malibu with H2IResmed, Ltd.200641—
+2K061200Prestige Cpap Flow Generator with Prestige HumidifierResmed, Ltd.20060—
+2K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd.2004961
+2K030797S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx…Resmed Corp200417—
+2K032480Autoset Spirit SystemResmed, Ltd.20036—
+2K030843Vpap IiiResmed, Ltd.2003106—
+2K024191S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd.2003110—
+3K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+3K131388Transcend Heated HumidifierSomnetics International, Inc.20131—
+3K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc.201210—
+3K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+3K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp.20094—
+3K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+3K082979S8 AdvanceResmed, Ltd.20093—
+3K080079S8 Escape IIResmed, Ltd.20084—
+3K080131Vpap STResmed, Ltd.200838—
+3K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+3K053607Breas Vivo 40 SystemBreas Medical AB200625—
+3K051314Res Traxx Data CenterResmed, Ltd.200516—
+3K050775ResscanResmed, Ltd.200520—
+3K043282Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical20050—
+3K034033RescanResmed, Ltd.200421—
+3K033841Resmed S8 Prime Cpap SystemResmed, Ltd.20041001
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+4K1329673B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc.20134—
+4K1317073B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems3B Medical, Inc.20134—
+4K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+4K120035Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp.20122—
+4K113815ResscanResmed, Ltd.201215—
+4K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+4K112393TasmanResmed, Ltd.20111—
+4K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+4K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+4K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical20100—
+4K092186Vpap TXResmed, Ltd.200918—
+4K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+4K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical200911
+4K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+4K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+4K082983Resscan-ProResmed, Ltd.200913—
+4K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB200824—
+4K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+4K053205Res Traxx Data CenterResmed, Ltd.200615—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K141770Luna Cpap and Auto-Cpap System3B Medical, Inc.20153—
+5K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+5K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+5K140159S9 Wanda Vpap STResmed, Ltd.20142—
+5K140054RescanResmed, Ltd.201410—
+5K140124S9 EloueraResmed Corp20148—
+5K132606S9 Cronulla for HerResmed, Ltd.20140—
+5K123511S9 Vpap TXResmed, Ltd.20131—
+5K123557Easycare OnlineResmed, Ltd.20139—
+5K121705GEOResmed, Ltd.20120—
+5K113714Vpap TXResmed, Ltd.20120—
+5K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K112914Vpap TXResmed, Ltd.20110—
+5K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+5K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+5K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+5K093684Easycare OnlineResmed, Ltd.201012—
+5K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+5K090113Breas Vivo 40 SystemBreas Medical AB200923—
+5K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+5K070746Restraxx Data Centre, Model R10Resmed, Ltd.200714—
+6K253553OrionResmed Corp20260—
+6K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.20260—
+6K254104ResScan EssentialsResmed Corp20260—
+6K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.20250—
+6K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+6K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+6K203126S10 KirraResmed Pty, Ltd.20200—
+6K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+6K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+6K180619BongoInnomed Healthscience, Inc.20181—
+6K160836Menai SystemResmed, Ltd.20166—
+6K160127iCodeConnect3B Medical, Inc.20160—
+6K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+6K153387Luna CPAP and Auto CPAP System3B Medical, Inc.20162—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC20160—
+6K152356SapphireRespironics, Inc.20164—
+6K151901AirViewResmed, Ltd.20151—
+6K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+6K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.20150—
+6K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+6K132371Easycare OnlineResmed, Ltd.20138—
+6K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+6K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+6K122324Vpap S-aResmed, Ltd.20120—
+6K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+6K122769Remstar SERespironics, Inc.20123Class I