510(k) Report

Devices descending from K192581

6 later devices reach The NightBlocks Appliance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191320Slow Wave DS8Slow Wave, Inc.20205—
+2K233754AIO BreatheAiomega, LLC20241—
+2K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+2K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+3K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+3K252525AIO BreatheAiomega, LLC20250—