510(k) Report

Devices descending from K030843

106 later devices reach Vpap Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062291Vpap Malibu with H2IResmed, Ltd.200641—
+1K053607Breas Vivo 40 SystemBreas Medical AB200625—
+1K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd.2004961
+2K082979S8 AdvanceResmed, Ltd.20093—
+2K080079S8 Escape IIResmed, Ltd.20084—
+2K080131Vpap STResmed, Ltd.200838—
+2K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB200824—
+2K071171Vpap Auto with H3IResmed, Ltd.200740—
+2K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+2K050775ResscanResmed, Ltd.200520—
+3K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+3K113815ResscanResmed, Ltd.201215—
+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
+3K090113Breas Vivo 40 SystemBreas Medical AB200923—
+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—
+4K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+4K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+4K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+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—
+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—
+4K103167Stellar 150Resmed Germany, Inc.201120—
+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
+5K253553OrionResmed Corp20260—
+5K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.20260—
+5K254104ResScan EssentialsResmed Corp20260—
+5K242931HFT750UMekics Co., Ltd.20250—
+5K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.20250—
+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—
+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—
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+5K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+6K261360EasyCare Tx 2Resmed Corp20260—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+6K251889myAirResmed Corp20260—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K242485EveryWareBreas Medical AB20250—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+6K200565GalapogosResmed Corp20213—
+6K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K183226Care Orchestrator EssenceRespironics, Inc.20190—
+6K181053Care OrchestratorRespironics, Inc.20191—
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+6K140279S9 GreenhillsResmed, Ltd.20142—
+6K122715Stellar 150Resmed Germany, Inc.20130Class I
+6K130077Remstar SERespironics, Inc.20132Class I
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K251770SleepRes PAP SystemSleepres, Inc.20250—
+7K241216myAirResmed Corp20242—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K212263Luna G3 BPAP System3B Medical, Inc.20220—
+7K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+7K181166Trilogy EvoRespironics, Inc.20195Class I
+8K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—