510(k) Report

Devices descending from K913083

8 later devices reach BI-Temp Temperature Monitor TM-201D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112376S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC20117—
+2K123361Esotest Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa20136—
+3K180047ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa20183—
+3K152402IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient…Securus,Inc20161—
+4K192210ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa20192—
+4K180148ATS Thermal Imaging Probe, ATS Patient Interface UnitSecurus Medical Group, Inc.20180—
+5K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC20211—
+6K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, Inc.20230—