510(k) Report

Devices descending from K013843

125 later devices reach Autoset Spirit Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121374ZI BlowerDeshum Medical20131—
+1K080797Humidaire 2IResmed, Ltd.20082—
+1K062291Vpap Malibu with H2IResmed, Ltd.200641—
+1K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd.2004961
+1K030797S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx…Resmed Corp200417—
+1K032480Autoset Spirit SystemResmed, Ltd.20036—
+1K024191S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd.2003110—
+2K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+2K131388Transcend Heated HumidifierSomnetics International, Inc.20131—
+2K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc.201210—
+2K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+2K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp.20094—
+2K082979S8 AdvanceResmed, Ltd.20093—
+2K080079S8 Escape IIResmed, Ltd.20084—
+2K080131Vpap STResmed, Ltd.200838—
+2K071171Vpap Auto with H3IResmed, Ltd.200740—
+2K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+2K051314Res Traxx Data CenterResmed, Ltd.200516—
+2K050775ResscanResmed, Ltd.200520—
+2K043282Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical20050—
+2K034033RescanResmed, Ltd.200421—
+2K033841Resmed S8 Prime Cpap SystemResmed, Ltd.20041001
+3K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+3K1329673B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc.20134—
+3K1317073B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems3B Medical, Inc.20134—
+3K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+3K120035Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp.20122—
+3K113815ResscanResmed, Ltd.201215—
+3K112393TasmanResmed, Ltd.20111—
+3K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+3K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+3K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical20100—
+3K092186Vpap TXResmed, Ltd.200918—
+3K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+3K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical200911
+3K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+3K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+3K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+3K082983Resscan-ProResmed, Ltd.200913—
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K061200Prestige Cpap Flow Generator with Prestige HumidifierResmed, Ltd.20060—
+3K053205Res Traxx Data CenterResmed, Ltd.200615—
+4K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+4K141770Luna Cpap and Auto-Cpap System3B Medical, Inc.20153—
+4K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+4K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+4K140159S9 Wanda Vpap STResmed, Ltd.20142—
+4K140054RescanResmed, Ltd.201410—
+4K140124S9 EloueraResmed Corp20148—
+4K132606S9 Cronulla for HerResmed, Ltd.20140—
+4K123511S9 Vpap TXResmed, Ltd.20131—
+4K123557Easycare OnlineResmed, Ltd.20139—
+4K121705GEOResmed, Ltd.20120—
+4K113714Vpap TXResmed, Ltd.20120—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K113288Vpap ST-aResmed, Ltd.20127—
+4K112914Vpap TXResmed, Ltd.20110—
+4K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+4K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+4K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K093684Easycare OnlineResmed, Ltd.201012—
+4K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K070746Restraxx Data Centre, Model R10Resmed, Ltd.200714—
+5K253553OrionResmed Corp20260—
+5K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.20260—
+5K254104ResScan EssentialsResmed Corp20260—
+5K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.20250—
+5K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+5K203126S10 KirraResmed Pty, Ltd.20200—
+5K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K160836Menai SystemResmed, Ltd.20166—
+5K160127iCodeConnect3B Medical, Inc.20160—
+5K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+5K153387Luna CPAP and Auto CPAP System3B Medical, Inc.20162—
+5K153061Juno VPAP ST-AResmed, Ltd.20163—
+5K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC20160—
+5K152356SapphireRespironics, Inc.20164—
+5K151901AirViewResmed, Ltd.20151—
+5K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+5K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.20150—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K132371Easycare OnlineResmed, Ltd.20138—
+5K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K122324Vpap S-aResmed, Ltd.20120—
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K122769Remstar SERespironics, Inc.20123Class I
+5K113801Vpap AdaptResmed Corp20125—
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K083816Res Traxx Online, Model: R14Resmed, Ltd.200913—
+6K261360EasyCare Tx 2Resmed Corp20260—
+6K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.20260—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+6K251889myAirResmed Corp20260—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K242485EveryWareBreas Medical AB20250—