510(k) Report

Devices descending from K102746

19 later devices reach Mirage FX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132013Swift AirResmed, Ltd.20131—
+1K123789Swift FX NanoResmed, Ltd.20138—
+1K123979Quattro AirResmed, Ltd.201391
+2K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+2K153563AirFit F20Resmed, Ltd.20166Class I
+2K150365Cloud9 SystemInsleep Technologies, LLC20150—
+2K132901Airsoft F15Resmed, Ltd.20140—
+2K132887Airfit N10Resmed, Ltd.20137Class I
+3K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+3K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+3K170924AirFit F20Resmed, Ltd.20183Class I
+3K153673AirFit N20Resmed, Ltd.20166—
+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—
+4K161978AirFit N20Resmed, Ltd.20165Class I
+5K261262Altis Full Face MaskRespironics, Inc.20260—
+5K171212AirFit N20Resmed, Ltd.20173Class I
+6K180497Scone MaskResmed, Ltd.20181—
+7K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—