510(k) Report

Devices descending from K121631

3 later devices reach Simple T Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140980TI Nasal MaskRespironics, Inc.20152Class I
+2K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+3K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—