510(k) Report

Devices descending from K980721

245 later devices reach Sullivan Autoset through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042403Mirage SwiftResmed, Ltd.200480—
+1K031935Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530Tiara Medical Systems, Inc.200423—
+1K032433Nasal Jacks MaskResmed, Ltd.200396—
+1K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc.200320—
+1K013843Autoset Spirit Cpap SystemResmed Corp2002125—
+1K013909S7 Elite CP AP SystemResmed Corp2002128—
+2K121374ZI BlowerDeshum Medical20131—
+2K1122713B Willow3B Products, LLC201211
+2K112489Swift FX BellaResmed, Ltd.20110—
+2K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+2K092362Sleepweaver Nasal Cpap MaskCircadiance, LLC20092—
+2K080797Humidaire 2IResmed, Ltd.20082—
+2K073638Swift LTResmed, Ltd.200817—
+2K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+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—
+2K063011Mirage Liberty Full Face MaskResmed, Ltd.20075—
+2K063122Mirage Quattro Full Face MaskResmed, Ltd.200738—
+2K063476Breas Isleep 20IBreas Medical AB200712—
+2K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+2K062291Vpap Malibu with H2IResmed, Ltd.200641—
+2K061200Prestige Cpap Flow Generator with Prestige HumidifierResmed, Ltd.20060—
+2K061057Breas Isleep 20+Breas Medical AB20060—
+2K053352Comfortlite Nasal MaskRespironics, Inc.200641—
+2K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—
+2K042945Aura Cpap SystemAeiomed, Inc.20056—
+2K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc.200521—
+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—
+3K183512Moore Park MaskResmed, Ltd.20192Class I
+3K172335Bleep DreamPortSnapcpap20180—
+3K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+3K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+3K131388Transcend Heated HumidifierSomnetics International, Inc.20131—
+3K121747Facefit and Facefit Ported Non-Invasive Ventilation MasksIntersurgical Incorporated20130—
+3K123979Quattro AirResmed, Ltd.201391
+3K120463Mojo, VerasealSleepnet Corporation20124Class I
+3K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc.201210—
+3K120757Sleepweaver Elan Nasal Cpap MaskCircadiance, LLC20121—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+3K113127Mirage QuattroResmed, Ltd.20124—
+3K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+3K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+3K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+3K091129Quattro LTResmed, Ltd.20090—
+3K090935Minime Pediatric MaskSleepnet Corporation20095—
+3K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp.20094—
+3K090244Swift FXResmed, Ltd.200915—
+3K082558Comfortlite Nasal MaskRespironics, Inc.200936—
+3K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+3K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+3K082979S8 AdvanceResmed, Ltd.20093—
+3K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+3K071915Cpap MaskArcimed Laboratories, LLC20080—
+3K080079S8 Escape IIResmed, Ltd.20084—
+3K080131Vpap STResmed, Ltd.200838—
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K072940Mirage MicroResmed, Ltd.200726—
+3K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+3K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation200620—
+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
+4K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+4K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20241—
+4K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+4K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+4K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+4K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+4K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+4K153563AirFit F20Resmed, Ltd.20166Class I
+4K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+4K150365Cloud9 SystemInsleep Technologies, LLC20150—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K132901Airsoft F15Resmed, Ltd.20140—
+4K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+4K132887Airfit N10Resmed, Ltd.20137Class I
+4K1329673B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc.20134—
+4K132013Swift AirResmed, Ltd.20131—
+4K132127Transcend AutoSomnetics International, Inc.20131—
+4K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+4K1317073B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems3B Medical, Inc.20134—
+4K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K123789Swift FX NanoResmed, Ltd.20138—
+4K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+4K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+4K120035Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp.20122—
+4K113815ResscanResmed, Ltd.201215—