510(k) Report

Devices descending from K091843

5 later devices reach Comfort Twin Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110405Trublue Nasal MaskRespironics, Inc.20114—
+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—