510(k) Report

Devices descending from K202529

2 later devices reach ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+2K254304iNOS intraoral biosensorAchaemenid, LLC20260—