510(k) Report

Devices descending from K063268

4 later devices reach Cpap/Vpap Masks, Models 1225, 1205 and 1235 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+1K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+1K072755Galemed Cpap MaskGalemed Corp.20070—
+2K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—