510(k) Report

Devices descending from K041209

96 later devices reach Resmed S8 Pioneer Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082979S8 AdvanceResmed, Ltd.20093—
+1K080079S8 Escape IIResmed, Ltd.20084—
+1K080131Vpap STResmed, Ltd.200838—
+1K071171Vpap Auto with H3IResmed, Ltd.200740—
+1K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+1K050775ResscanResmed, Ltd.200520—
+2K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+2K113815ResscanResmed, Ltd.201215—
+2K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+2K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical20100—
+2K092186Vpap TXResmed, Ltd.200918—
+2K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+2K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical200911
+2K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+2K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+2K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+2K082983Resscan-ProResmed, Ltd.200913—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+3K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+3K140159S9 Wanda Vpap STResmed, Ltd.20142—
+3K140054RescanResmed, Ltd.201410—
+3K140124S9 EloueraResmed Corp20148—
+3K132606S9 Cronulla for HerResmed, Ltd.20140—
+3K123511S9 Vpap TXResmed, Ltd.20131—
+3K123557Easycare OnlineResmed, Ltd.20139—
+3K113714Vpap TXResmed, Ltd.20120—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K113288Vpap ST-aResmed, Ltd.20127—
+3K112914Vpap TXResmed, Ltd.20110—
+3K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+3K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+3K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+3K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+3K093684Easycare OnlineResmed, Ltd.201012—
+3K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K253553OrionResmed Corp20260—
+4K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.20260—
+4K254104ResScan EssentialsResmed Corp20260—
+4K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.20250—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K180619BongoInnomed Healthscience, Inc.20181—
+4K160836Menai SystemResmed, Ltd.20166—
+4K160127iCodeConnect3B Medical, Inc.20160—
+4K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+4K153061Juno VPAP ST-AResmed, Ltd.20163—
+4K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC20160—
+4K152356SapphireRespironics, Inc.20164—
+4K151901AirViewResmed, Ltd.20151—
+4K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+4K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.20150—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K132371Easycare OnlineResmed, Ltd.20138—
+4K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122324Vpap S-aResmed, Ltd.20120—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K122769Remstar SERespironics, Inc.20123Class I
+4K113801Vpap AdaptResmed Corp20125—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+4K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+5K261360EasyCare Tx 2Resmed Corp20260—
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K251889myAirResmed Corp20260—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K242485EveryWareBreas Medical AB20250—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+5K200565GalapogosResmed Corp20213—
+5K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K181053Care OrchestratorRespironics, Inc.20191—
+5K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K140279S9 GreenhillsResmed, Ltd.20142—
+5K130077Remstar SERespironics, Inc.20132Class I
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+6K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+6K251770SleepRes PAP SystemSleepres, Inc.20250—
+6K241216myAirResmed Corp20242—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K212263Luna G3 BPAP System3B Medical, Inc.20220—
+6K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K250624myAirResmed Corp20251—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+8K233452Vivo 45 LSBreas Medical AB202501