510(k) Report

Devices descending from K150572

5 later devices reach Respire Pink Series-Herbst-EF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+1K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+1K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+2K214096Respire ClearRespire Medical, LLC20220—
+2K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—