510(k) Report

Devices descending from K050142

28 later devices reach Resmed Meridian Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071808Mirage MicroResmed, Ltd.200727—
+2K090490Mirage EchoResmed Corp20091—
+2K072940Mirage MicroResmed, Ltd.200726—
+3K112489Swift FX BellaResmed, Ltd.20110—
+3K110444Mirage MicroResmed, Ltd.20110—
+3K102746Mirage FXResmed, Ltd.201019—
+3K093731Vpap Iii ST-aResmed, Ltd.20100—
+3K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+3K081321Modification to Mirage MicroResmed, Ltd.20082—
+4K132013Swift AirResmed, Ltd.20131—
+4K123789Swift FX NanoResmed, Ltd.20138—
+4K123979Quattro AirResmed, Ltd.201391
+5K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+5K153563AirFit F20Resmed, Ltd.20166Class I
+5K150365Cloud9 SystemInsleep Technologies, LLC20150—
+5K132901Airsoft F15Resmed, Ltd.20140—
+5K132887Airfit N10Resmed, Ltd.20137Class I
+6K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+6K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+6K170924AirFit F20Resmed, Ltd.20183Class I
+6K153673AirFit N20Resmed, Ltd.20166—
+7K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+7K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+7K161978AirFit N20Resmed, Ltd.20165Class I
+8K261262Altis Full Face MaskRespironics, Inc.20260—
+8K171212AirFit N20Resmed, Ltd.20173Class I
+9K180497Scone MaskResmed, Ltd.20181—
+10K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—