510(k) Report

Devices descending from K023244

113 later devices reach Mirage Full Face Mask Series 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132901Airsoft F15Resmed, Ltd.20140—
+1K123979Quattro AirResmed, Ltd.201391
+1K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+1K070321Twilight Full Face MaskInvacare Corp.20070—
+1K063011Mirage Liberty Full Face MaskResmed, Ltd.20075—
+1K063122Mirage Quattro Full Face MaskResmed, Ltd.200738—
+1K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20062—
+1K042403Mirage SwiftResmed, Ltd.200480—
+1K041362Resmed Hospital Full Face MaskResmed, Ltd.20042—
+1K040506Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd.2004386
+1K031896Nasal-Air Critical CareInnomed Technologies20040—
+1K032916Mirage Activa MaskResmed, Ltd.200393—
+2K183512Moore Park MaskResmed, Ltd.20192Class I
+2K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+2K153563AirFit F20Resmed, Ltd.20166Class I
+2K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—
+2K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+2K121747Facefit and Facefit Ported Non-Invasive Ventilation MasksIntersurgical Incorporated20130—
+2K120463Mojo, VerasealSleepnet Corporation20124Class I
+2K1122713B Willow3B Products, LLC201211
+2K113127Mirage QuattroResmed, Ltd.20124—
+2K112489Swift FX BellaResmed, Ltd.20110—
+2K092362Sleepweaver Nasal Cpap MaskCircadiance, LLC20092—
+2K091843Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K091066Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20090—
+2K091129Quattro LTResmed, Ltd.20090—
+2K071915Cpap MaskArcimed Laboratories, LLC20080—
+2K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+2K073638Swift LTResmed, Ltd.200817—
+2K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+2K072940Mirage MicroResmed, Ltd.200726—
+2K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+2K061236Flexifit HC432 Full Face MaskFisher & Paykel Healthcare, Ltd.200625—
+2K060044Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd.20067—
+2K052249UtopiaRespcare, Inc.20050—
+2K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—
+2K050359Ultra Mirage II MaskResmed, Ltd.200539—
+3K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+3K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+3K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20241—
+3K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+3K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+3K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+3K172335Bleep DreamPortSnapcpap20180—
+3K170924AirFit F20Resmed, Ltd.20183Class I
+3K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…Fisher and Paykel Healthcare Limited20171—
+3K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+3K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+3K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+3K132887Airfit N10Resmed, Ltd.20137Class I
+3K132013Swift AirResmed, Ltd.20131—
+3K130663BESTFIT2 Nasal MaskCurative Medical, Inc.20130—
+3K123789Swift FX NanoResmed, Ltd.20138—
+3K120757Sleepweaver Elan Nasal Cpap MaskCircadiance, LLC20121—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+3K112393TasmanResmed, Ltd.20111—
+3K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—
+3K110405Trublue Nasal MaskRespironics, Inc.20114—
+3K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+3K110444Mirage MicroResmed, Ltd.20110—
+3K102746Mirage FXResmed, Ltd.201019—
+3K093731Vpap Iii ST-aResmed, Ltd.20100—
+3K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+3K090490Mirage EchoResmed Corp20091—
+3K090244Swift FXResmed, Ltd.200915—
+3K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+3K083122Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd.20094—
+3K081321Modification to Mirage MicroResmed, Ltd.20082—
+3K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+3K071808Mirage MicroResmed, Ltd.200727—
+3K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC20060—
+4K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+4K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+4K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+4K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+4K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+4K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+4K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited20200—
+4K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+4K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+4K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+4K153673AirFit N20Resmed, Ltd.20166—
+4K150365Cloud9 SystemInsleep Technologies, LLC20150—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+4K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K121705GEOResmed, Ltd.20120—
+4K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+4K1034343B Flex-Lite3B Products, LLC20110—
+4K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+4K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+5K261262Altis Full Face MaskRespironics, Inc.20260—
+5K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+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—
+5K161978AirFit N20Resmed, Ltd.20165Class I