510(k) Report

Devices descending from K013306

6 later devices reach Minime Nasal Mask, Model P/N 50220 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090935Minime Pediatric MaskSleepnet Corporation20095—
+2K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+2K102224Pixi Pediatric MaskResmed, Ltd.20103—
+3K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+3K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+4K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—