510(k) Report

Devices descending from K131138

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+1K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+1K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+1K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+2K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+2K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+3K214096Respire ClearRespire Medical, LLC20220—