510(k) Report

Devices descending from K900164

107 later devices reach Airway Delivery & Management (Adam) Nasal Ventila. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071773Cpap Nasal Mask with PillowsLifesource20070—
+1K032433Nasal Jacks MaskResmed, Ltd.200396—
+1K020641Spiritus (TM) Respiratory System #SRS 001Worldwide Medical Technologies, LLC200210—
+1K951944NasalflairAirways Ltd., Inc.19970—
+2K053352Comfortlite Nasal MaskRespironics, Inc.200641—
+2K042403Mirage SwiftResmed, Ltd.200480—
+2K033759C2 Nasal MaskRespironics, Inc.20049—
+3K1122713B Willow3B Products, LLC201211
+3K112489Swift FX BellaResmed, Ltd.20110—
+3K092362Sleepweaver Nasal Cpap MaskCircadiance, LLC20092—
+3K090935Minime Pediatric MaskSleepnet Corporation20095—
+3K082558Comfortlite Nasal MaskRespironics, Inc.200936—
+3K073638Swift LTResmed, Ltd.200817—
+3K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+3K063011Mirage Liberty Full Face MaskResmed, Ltd.20075—
+3K063122Mirage Quattro Full Face MaskResmed, Ltd.200738—
+3K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+3K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—
+3K042130Aura Cpap Patient InterfaceAeiomed, Inc.20048—
+4K183512Moore Park MaskResmed, Ltd.20192Class I
+4K172335Bleep DreamPortSnapcpap20180—
+4K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+4K121747Facefit and Facefit Ported Non-Invasive Ventilation MasksIntersurgical Incorporated20130—
+4K123979Quattro AirResmed, Ltd.201391
+4K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+4K120463Mojo, VerasealSleepnet Corporation20124Class I
+4K120757Sleepweaver Elan Nasal Cpap MaskCircadiance, LLC20121—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+4K113127Mirage QuattroResmed, Ltd.20124—
+4K102515NP15Weinmann Gerate Fur Medizin GmbH + Co. KG20110—
+4K102746Mirage FXResmed, Ltd.201019—
+4K102502Golife Nasal MaskRespironics, Inc.20109—
+4K102224Pixi Pediatric MaskResmed, Ltd.20103—
+4K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+4K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+4K091129Quattro LTResmed, Ltd.20090—
+4K090244Swift FXResmed, Ltd.200915—
+4K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+4K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+4K071915Cpap MaskArcimed Laboratories, LLC20080—
+4K072940Mirage MicroResmed, Ltd.200726—
+5K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+5K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20241—
+5K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+5K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+5K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+5K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+5K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+5K153563AirFit F20Resmed, Ltd.20166Class I
+5K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+5K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+5K150365Cloud9 SystemInsleep Technologies, LLC20150—
+5K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K132901Airsoft F15Resmed, Ltd.20140—
+5K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+5K132013Swift AirResmed, Ltd.20131—
+5K132127Transcend AutoSomnetics International, Inc.20131—
+5K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+5K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K123789Swift FX NanoResmed, Ltd.20138—
+5K121374ZI BlowerDeshum Medical20131—
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+5K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+5K1034343B Flex-Lite3B Products, LLC20110—
+5K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+5K110444Mirage MicroResmed, Ltd.20110—
+5K110008Golife Nasal MaskRespironics, Inc.20115—
+5K093731Vpap Iii ST-aResmed, Ltd.20100—
+5K090490Mirage EchoResmed Corp20091—
+5K081321Modification to Mirage MicroResmed, Ltd.20082—
+6K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+6K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+6K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+6K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+6K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+6K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+6K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+6K170924AirFit F20Resmed, Ltd.20183Class I
+6K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+6K132887Airfit N10Resmed, Ltd.20137Class I
+6K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+6K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+6K121631Simple T Nasal MaskRespironics, Inc.20123Class I
+6K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+7K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+7K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+7K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+7K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+7K153673AirFit N20Resmed, Ltd.20166—
+7K140980TI Nasal MaskRespironics, Inc.20152Class I
+8K261262Altis Full Face MaskRespironics, Inc.20260—
+8K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—