510(k) Report

Devices descending from K190236

5 later devices reach O2Vent Optima through their predicates, nearest generation first.

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