510(k) Report

Devices descending from K930656

184 later devices reach Sullivan Iii Nasal Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033841Resmed S8 Prime Cpap SystemResmed, Ltd.20041001
+1K022192Pegasus Nasal Cpap SystemSensor Medics Corp.20030—
+1K990856Heritage Nasal Cpap System, Model P/N 15682Bird Products Corp.20002—
+1K982242Invacare CpapInvacare Corp.19992—
+1K973161Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd.1998110—
+2K112393TasmanResmed, Ltd.20111—
+2K080079S8 Escape IIResmed, Ltd.20084—
+2K071069Mini Cpap Device and Humidifier AccessoryViasys Sleep Systems, LLC20070—
+2K061200Prestige Cpap Flow Generator with Prestige HumidifierResmed, Ltd.20060—
+2K052597Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC20057—
+2K041823Pioneer U121 Series CpapMerits Health Products Co., Ltd.20050—
+2K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd.2004961
+2K040941Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd.200498—
+2K041035Hoffrichter Trend 110 Cpap Device with Aquatrend Iii Cpap Humidifier Accessory for TrendHoffrichter GmbH20041—
+2K031064Invacare Polaris EX Cpap, Model ISP3000Invacare Corp.20040—
+2K014074Hoffrichter Vector, Vector Plus, Vector BI-Vevel, Vector BI-Level Plus, Scalar, Scalar…Hoffrichter GmbH20032—
+2K020730Orion Nasal Cpap SystemBird Products Corp.20021—
+3K121374ZI BlowerDeshum Medical20131—
+3K121705GEOResmed, Ltd.20120—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+3K082979S8 AdvanceResmed, Ltd.20093—
+3K081029Sleepstyle 200 Auto Series HC254Fisher & Paykel Healthcare, Ltd.20084—
+3K080131Vpap STResmed, Ltd.200838—
+3K071171Vpap Auto with H3IResmed, Ltd.200740—
+3K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+3K053486Trend 200 Cpap Device, Model 5CP201; Trendset PC Software, Model TrendsetHoffrichter GmbH20060—
+3K050904Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd.200525—
+3K050775ResscanResmed, Ltd.200520—
+3K041900HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd.200474—
+4K150365Cloud9 SystemInsleep Technologies, LLC20150—
+4K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K132127Transcend AutoSomnetics International, Inc.20131—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K113815ResscanResmed, Ltd.201215—
+4K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+4K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+4K094040F&P Icon Series CpapFisher & Paykel Healthcare, Ltd.201011
+4K100104Hybernite Rainout Control SystemPlastiflex Group NV20106—
+4K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+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—
+4K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+4K082983Resscan-ProResmed, Ltd.200913—
+4K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+4K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+5K173193F&P SleepStyleFisher & Paykel Healthcare, Ltd.20180—
+5K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+5K140159S9 Wanda Vpap STResmed, Ltd.20142—
+5K140054RescanResmed, Ltd.201410—
+5K140124S9 EloueraResmed Corp20148—
+5K132606S9 Cronulla for HerResmed, Ltd.20140—
+5K122705Humicare D900Grundler GmbH20131—
+5K123511S9 Vpap TXResmed, Ltd.20131—
+5K123557Easycare OnlineResmed, Ltd.20139—
+5K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+5K113714Vpap TXResmed, Ltd.20120—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+5K1122713B Willow3B Products, LLC201211
+5K112914Vpap TXResmed, Ltd.20110—
+5K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+5K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+5K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+5K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+5K103316FlowrestVapotherm, Inc.20113—
+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
+5K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+5K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+5K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+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—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K203126S10 KirraResmed Pty, Ltd.20200—
+6K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+6K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+6K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+6K180619BongoInnomed Healthscience, Inc.20181—
+6K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+6K160836Menai SystemResmed, Ltd.20166—
+6K160127iCodeConnect3B Medical, Inc.20160—
+6K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC20160—
+6K152356SapphireRespironics, Inc.20164—