510(k) Report

Devices descending from K111207

11 later devices reach Respire Blue Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152292Respire Blue Series-EFRespire Medical Holding20150—
+1K131138Respire Pink Series - HerbstRespire Medical20137—
+1K121344NU SleepRh Associates, LLC20120—
+1K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+2K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+2K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+2K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+3K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+3K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+4K214096Respire ClearRespire Medical, LLC20220—