510(k) Report

Devices descending from K102037

11 later devices reach Autosure Voice II Blood Glucose Monitoring System and Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212140GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+1K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose…Apex BioTechnology Corp.20150—
+1K113098Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus IiiApex BioTechnology Corp.20125—
+1K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc.201121
+2K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.20143—
+2K120064Test, Blood Glucose SystemHmd Biomedical, Inc.20121—
+2K120649Autosure Voice 3 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20120—
+3K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20162—
+3K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.20140—
+4K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+4K182992BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp.20180—