510(k) Report

Devices descending from K954207

22 later devices reach Gel Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090935Minime Pediatric MaskSleepnet Corporation20095—
+1K073600Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group200820—
+1K042455Devilbiss Nasal Cpap Mask, 9354 SeriesSunrise Medical20050—
+2K140580Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics)20150—
+2K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+2K102224Pixi Pediatric MaskResmed, Ltd.20103—
+2K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group201010—
+2K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group20092Class I
+3K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+3K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+3K142554Revolution Full Face MaskRespironics, Inc.20150Class I
+3K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+3K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+3K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+3K110405Trublue Nasal MaskRespironics, Inc.20114—
+3K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+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—
+4K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+5K140980TI Nasal MaskRespironics, Inc.20152Class I
+6K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+7K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—