510(k) Report

Devices descending from K063122

38 later devices reach Mirage Quattro Full Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123979Quattro AirResmed, Ltd.201391
+1K120463Mojo, VerasealSleepnet Corporation20124Class I
+1K113127Mirage QuattroResmed, Ltd.20124—
+1K112489Swift FX BellaResmed, Ltd.20110—
+1K091129Quattro LTResmed, Ltd.20090—
+1K071915Cpap MaskArcimed Laboratories, LLC20080—
+1K072940Mirage MicroResmed, Ltd.200726—
+2K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+2K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+2K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+2K153563AirFit F20Resmed, Ltd.20166Class I
+2K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+2K132901Airsoft F15Resmed, Ltd.20140—
+2K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+2K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+2K110444Mirage MicroResmed, Ltd.20110—
+2K102746Mirage FXResmed, Ltd.201019—
+2K093731Vpap Iii ST-aResmed, Ltd.20100—
+2K090490Mirage EchoResmed Corp20091—
+2K081321Modification to Mirage MicroResmed, Ltd.20082—
+3K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+3K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+3K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+3K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+3K170924AirFit F20Resmed, Ltd.20183Class I
+3K132013Swift AirResmed, Ltd.20131—
+3K123789Swift FX NanoResmed, Ltd.20138—
+3K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+4K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+4K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+4K150365Cloud9 SystemInsleep Technologies, LLC20150—
+4K132887Airfit N10Resmed, Ltd.20137Class I
+5K261262Altis Full Face MaskRespironics, Inc.20260—
+5K153673AirFit N20Resmed, Ltd.20166—
+6K161978AirFit N20Resmed, Ltd.20165Class I
+7K171212AirFit N20Resmed, Ltd.20173Class I
+8K180497Scone MaskResmed, Ltd.20181—
+9K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—