510(k) Report

Devices descending from K980721

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+4K112393TasmanResmed, Ltd.20111—
+4K1034343B Flex-Lite3B Products, LLC20110—
+4K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+4K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+4K110444Mirage MicroResmed, Ltd.20110—
+4K102515NP15Weinmann Gerate Fur Medizin GmbH + Co. KG20110—
+4K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+4K102746Mirage FXResmed, Ltd.201019—
+4K102502Golife Nasal MaskRespironics, Inc.20109—
+4K102224Pixi Pediatric MaskResmed, Ltd.20103—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K093731Vpap Iii ST-aResmed, Ltd.20100—
+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—
+4K090490Mirage EchoResmed Corp20091—
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K082983Resscan-ProResmed, Ltd.200913—
+4K081321Modification to Mirage MicroResmed, Ltd.20082—
+4K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+4K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB200824—
+4K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+4K053205Res Traxx Data CenterResmed, Ltd.200615—
+5K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+5K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+5K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+5K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+5K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+5K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K170924AirFit F20Resmed, Ltd.20183Class I
+5K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K153673AirFit N20Resmed, Ltd.20166—
+5K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+5K141770Luna Cpap and Auto-Cpap System3B Medical, Inc.20153—
+5K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+5K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+5K140159S9 Wanda Vpap STResmed, Ltd.20142—
+5K140054RescanResmed, Ltd.201410—
+5K140124S9 EloueraResmed Corp20148—
+5K132606S9 Cronulla for HerResmed, Ltd.20140—
+5K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+5K123511S9 Vpap TXResmed, Ltd.20131—
+5K123557Easycare OnlineResmed, Ltd.20139—
+5K121705GEOResmed, Ltd.20120—
+5K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+5K113714Vpap TXResmed, Ltd.20120—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K112914Vpap TXResmed, Ltd.20110—
+5K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+5K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+5K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+5K110008Golife Nasal MaskRespironics, Inc.20115—
+5K093684Easycare OnlineResmed, Ltd.201012—
+5K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+5K090113Breas Vivo 40 SystemBreas Medical AB200923—
+5K070746Restraxx Data Centre, Model R10Resmed, Ltd.200714—
+6K253553OrionResmed Corp20260—
+6K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.20260—
+6K254104ResScan EssentialsResmed Corp20260—
+6K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+6K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+6K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.20250—
+6K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+6K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+6K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+6K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+6K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+6K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+6K203126S10 KirraResmed Pty, Ltd.20200—
+6K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+6K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+6K160836Menai SystemResmed, Ltd.20166—
+6K161978AirFit N20Resmed, Ltd.20165Class I
+6K160127iCodeConnect3B Medical, Inc.20160—
+6K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+6K153387Luna CPAP and Auto CPAP System3B Medical, Inc.20162—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC20160—
+6K152356SapphireRespironics, Inc.20164—
+6K151901AirViewResmed, Ltd.20151—
+6K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+6K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.20150—
+6K132371Easycare OnlineResmed, Ltd.20138—
+6K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+6K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+6K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+6K122324Vpap S-aResmed, Ltd.20120—
+6K122769Remstar SERespironics, Inc.20123Class I
+6K121631Simple T Nasal MaskRespironics, Inc.20123Class I