510(k) Report

Devices descending from K000705

9 later devices reach Respironics Silhouette Nasal Mask, Models 1003224 and 1003223 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.20113—
+1K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd.20074Class I
+2K193206WiZARD 510 Nasal MaskApex Medical Corp.20200—
+2K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp.20191—
+2K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+2K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+2K072755Galemed Cpap MaskGalemed Corp.20070—
+3K243023WiZARD 520 Full Face MaskWellell, Inc.20250—
+3K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—