510(k) Report

Devices descending from K171316

6 later devices reach O2Vent W through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+2K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+2K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+3K252942ShaeferHShaeferh, LLC20260—
+3K232735EMA 3DEma Sleep Incorporated20241—
+4K252698NightGuard Aire MaxNightguard Express, LLC20250—