510(k) Report

Devices descending from K153291

3 later devices reach Sicat Optisleep through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+1K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+2K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—