510(k) Report

Devices descending from K050359

39 later devices reach Ultra Mirage II Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132887Airfit N10Resmed, Ltd.20137Class I
+1K132013Swift AirResmed, Ltd.20131—
+1K130663BESTFIT2 Nasal MaskCurative Medical, Inc.20130—
+1K123789Swift FX NanoResmed, Ltd.20138—
+1K112489Swift FX BellaResmed, Ltd.20110—
+1K112393TasmanResmed, Ltd.20111—
+1K102746Mirage FXResmed, Ltd.201019—
+1K091129Quattro LTResmed, Ltd.20090—
+1K090490Mirage EchoResmed Corp20091—
+1K090244Swift FXResmed, Ltd.200915—
+1K073638Swift LTResmed, Ltd.200817—
+1K071808Mirage MicroResmed, Ltd.200727—
+1K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC20060—
+2K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+2K172335Bleep DreamPortSnapcpap20180—
+2K153673AirFit N20Resmed, Ltd.20166—
+2K150365Cloud9 SystemInsleep Technologies, LLC20150—
+2K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+2K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+2K123979Quattro AirResmed, Ltd.201391
+2K121705GEOResmed, Ltd.20120—
+2K1034343B Flex-Lite3B Products, LLC20110—
+2K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+2K072940Mirage MicroResmed, Ltd.200726—
+3K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+3K161978AirFit N20Resmed, Ltd.20165Class I
+3K153563AirFit F20Resmed, Ltd.20166Class I
+3K132901Airsoft F15Resmed, Ltd.20140—
+3K110444Mirage MicroResmed, Ltd.20110—
+3K093731Vpap Iii ST-aResmed, Ltd.20100—
+3K081321Modification to Mirage MicroResmed, Ltd.20082—
+4K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+4K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+4K170924AirFit F20Resmed, Ltd.20183Class I
+4K171212AirFit N20Resmed, Ltd.20173Class I
+5K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+5K180497Scone MaskResmed, Ltd.20181—
+6K261262Altis Full Face MaskRespironics, Inc.20260—
+6K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—