510(k) Report

Devices descending from K053352

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090935Minime Pediatric MaskSleepnet Corporation20095—
+1K082558Comfortlite Nasal MaskRespironics, Inc.200936—
+2K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+2K1122713B Willow3B Products, LLC201211
+2K102515NP15Weinmann Gerate Fur Medizin GmbH + Co. KG20110—
+2K102746Mirage FXResmed, Ltd.201019—
+2K102502Golife Nasal MaskRespironics, Inc.20109—
+2K102224Pixi Pediatric MaskResmed, Ltd.20103—
+2K092362Sleepweaver Nasal Cpap MaskCircadiance, LLC20092—
+3K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+3K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+3K132013Swift AirResmed, Ltd.20131—
+3K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+3K123789Swift FX NanoResmed, Ltd.20138—
+3K123979Quattro AirResmed, Ltd.201391
+3K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+3K120757Sleepweaver Elan Nasal Cpap MaskCircadiance, LLC20121—
+3K110008Golife Nasal MaskRespironics, Inc.20115—
+4K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+4K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+4K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+4K153563AirFit F20Resmed, Ltd.20166Class I
+4K150365Cloud9 SystemInsleep Technologies, LLC20150—
+4K132901Airsoft F15Resmed, Ltd.20140—
+4K132887Airfit N10Resmed, Ltd.20137Class I
+4K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+4K121631Simple T Nasal MaskRespironics, Inc.20123Class I
+5K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+5K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+5K170924AirFit F20Resmed, Ltd.20183Class I
+5K153673AirFit N20Resmed, Ltd.20166—
+5K140980TI Nasal MaskRespironics, Inc.20152Class I
+6K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+6K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+6K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+6K161978AirFit N20Resmed, Ltd.20165Class I
+7K261262Altis Full Face MaskRespironics, Inc.20260—
+7K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+7K171212AirFit N20Resmed, Ltd.20173Class I
+8K180497Scone MaskResmed, Ltd.20181—
+9K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—