510(k) Report

Devices descending from K092835

10 later devices reach Comfortgel Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+1K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+1K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+1K110405Trublue Nasal MaskRespironics, Inc.20114—
+1K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+2K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+2K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+3K140980TI Nasal MaskRespironics, Inc.20152Class I
+4K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+5K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—