510(k) Report

Devices descending from K961783

233 later devices reach Sullivan Vpap II ST Nasal Vpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080131Vpap STResmed, Ltd.200838—
+1K050359Ultra Mirage II MaskResmed, Ltd.200539—
+1K050142Resmed Meridian MaskResmed, Ltd.200528—
+1K040944Rescontrol IIResmed, Ltd.20045—
+1K040566Resmed Hospital Nasal MaskResmed, Ltd.20040—
+1K032834Bipap Pro 2 BI-Level SystemRespironics, Inc.200440—
+1K032056Bilevel Cpap, Model 9055 SeriesSunrise Medical20044—
+1K032916Mirage Activa MaskResmed, Ltd.200393—
+1K031047Mirage Vista MaskResmed, Ltd.200356—
+1K030843Vpap IiiResmed, Ltd.2003106—
+1K030798Mirage Activa MaskResmed, Ltd.200396—
+2K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+2K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+2K132887Airfit N10Resmed, Ltd.20137Class I
+2K132013Swift AirResmed, Ltd.20131—
+2K130663BESTFIT2 Nasal MaskCurative Medical, Inc.20130—
+2K123789Swift FX NanoResmed, Ltd.20138—
+2K112489Swift FX BellaResmed, Ltd.20110—
+2K112393TasmanResmed, Ltd.20111—
+2K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+2K102746Mirage FXResmed, Ltd.201019—
+2K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical20100—
+2K092186Vpap TXResmed, Ltd.200918—
+2K092026Easycare TX, TX LinkResmed, Ltd.20092—
+2K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical200911
+2K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+2K091843Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K091066Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20090—
+2K091129Quattro LTResmed, Ltd.20090—
+2K090490Mirage EchoResmed Corp20091—
+2K090244Swift FXResmed, Ltd.200915—
+2K073638Swift LTResmed, Ltd.200817—
+2K072615TxcontrolResmed, Ltd.20083—
+2K071808Mirage MicroResmed, Ltd.200727—
+2K063501Knightcontrol Remote Control, Model M-114700-USMallinckrodt Developpement France20070—
+2K062291Vpap Malibu with H2IResmed, Ltd.200641—
+2K061874Invacare's Twilight II Nasal MasksInvacare Corp.20060—
+2K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC20060—
+2K060067Maskmedic Concept Nasal MaskMaskmedic20060—
+2K060105Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd.200653—
+2K053607Breas Vivo 40 SystemBreas Medical AB200625—
+2K043282Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical20050—
+2K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc.200539—
+2K042403Mirage SwiftResmed, Ltd.200480—
+2K042294Slumbergear (TM), Model Multiple (004, 005, 005, 007)Suiter Enterprises, Inc.20041—
+2K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd.2004961
+3K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+3K172335Bleep DreamPortSnapcpap20180—
+3K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+3K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+3K153673AirFit N20Resmed, Ltd.20166—
+3K150365Cloud9 SystemInsleep Technologies, LLC20150—
+3K140159S9 Wanda Vpap STResmed, Ltd.20142—
+3K140124S9 EloueraResmed Corp20148—
+3K132606S9 Cronulla for HerResmed, Ltd.20140—
+3K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+3K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+3K123511S9 Vpap TXResmed, Ltd.20131—
+3K123979Quattro AirResmed, Ltd.201391
+3K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+3K121705GEOResmed, Ltd.20120—
+3K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+3K113714Vpap TXResmed, Ltd.20120—
+3K113780Easycare TX System (Connexuns)Resmed, Ltd.20121—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K113288Vpap ST-aResmed, Ltd.20127—
+3K1122713B Willow3B Products, LLC201211
+3K112914Vpap TXResmed, Ltd.20110—
+3K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+3K1034343B Flex-Lite3B Products, LLC20110—
+3K110405Trublue Nasal MaskRespironics, Inc.20114—
+3K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+3K103167Stellar 150Resmed Germany, Inc.201120—
+3K100343Pap-CapPur-Sleep, Inc.20100—
+3K093731Vpap Iii ST-aResmed, Ltd.20100—
+3K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+3K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+3K092362Sleepweaver Nasal Cpap MaskCircadiance, LLC20092—
+3K090935Minime Pediatric MaskSleepnet Corporation20095—
+3K082979S8 AdvanceResmed, Ltd.20093—
+3K080079S8 Escape IIResmed, Ltd.20084—
+3K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB200824—
+3K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+3K072940Mirage MicroResmed, Ltd.200726—
+3K071171Vpap Auto with H3IResmed, Ltd.200740—
+3K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+3K063540Bipap AutosvRespironics, Inc.200713—
+3K063533Bipap SynchronyRespironics, Inc.200730—
+3K063011Mirage Liberty Full Face MaskResmed, Ltd.20075—
+3K063122Mirage Quattro Full Face MaskResmed, Ltd.200738—
+3K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+3K061034Bipap Plus M-Series BI-Level SystemRespironics, Inc.20060—
+3K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—
+3K050759Bipap AutoRespironics, Inc.2005371
+3K050775ResscanResmed, Ltd.200520—
+4K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+4K241939EasyCare Tx 2Resmed Corp20240—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+4K183512Moore Park MaskResmed, Ltd.20192Class I