510(k) Report

Devices descending from K102502

9 later devices reach Golife Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+1K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+1K110008Golife Nasal MaskRespironics, Inc.20115—
+2K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+2K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+2K121631Simple T Nasal MaskRespironics, Inc.20123Class I
+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—