510(k) Report

Devices descending from K082558

36 later devices reach Comfortlite Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1122713B Willow3B Products, LLC201211
+1K102515NP15Weinmann Gerate Fur Medizin GmbH + Co. KG20110—
+1K102746Mirage FXResmed, Ltd.201019—
+1K102502Golife Nasal MaskRespironics, Inc.20109—
+1K092362Sleepweaver Nasal Cpap MaskCircadiance, LLC20092—
+2K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+2K132013Swift AirResmed, Ltd.20131—
+2K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+2K123789Swift FX NanoResmed, Ltd.20138—
+2K123979Quattro AirResmed, Ltd.201391
+2K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+2K120757Sleepweaver Elan Nasal Cpap MaskCircadiance, LLC20121—
+2K110008Golife Nasal MaskRespironics, Inc.20115—
+3K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+3K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+3K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+3K153563AirFit F20Resmed, Ltd.20166Class I
+3K150365Cloud9 SystemInsleep Technologies, LLC20150—
+3K132901Airsoft F15Resmed, Ltd.20140—
+3K132887Airfit N10Resmed, Ltd.20137Class I
+3K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+3K121631Simple T Nasal MaskRespironics, Inc.20123Class I
+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
+4K153673AirFit N20Resmed, Ltd.20166—
+4K140980TI Nasal MaskRespironics, Inc.20152Class I
+5K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+5K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+5K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+5K161978AirFit N20Resmed, Ltd.20165Class I
+6K261262Altis Full Face MaskRespironics, Inc.20260—
+6K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+6K171212AirFit N20Resmed, Ltd.20173Class I
+7K180497Scone MaskResmed, Ltd.20181—
+8K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—