510(k) Report

Devices descending from K042161

109 later devices reach Anti-Snoring/Sleep Apnea Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191320Slow Wave DS8Slow Wave, Inc.20205—
+5K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+5K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+5K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—
+6K233754AIO BreatheAiomega, LLC20241—
+6K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+6K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+6K214096Respire ClearRespire Medical, LLC20220—
+7K252525AIO BreatheAiomega, LLC20250—