510(k) Report

Devices descending from K160234

8 later devices reach OVENT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+1K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+2K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+3K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+3K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+4K252942ShaeferHShaeferh, LLC20260—
+4K232735EMA 3DEma Sleep Incorporated20241—
+5K252698NightGuard Aire MaxNightguard Express, LLC20250—