510(k) Report

Devices descending from K011233

19 later devices reach Modification to Glucosure BGM System, Model 221100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp.200718—
+2K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc.201121
+2K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp.200813—
+2K073137Glucosure Voice Blood Glucose Monitoring System, Model AS90011E1Apex BioTechnology Corp.20080—
+3K120064Test, Blood Glucose SystemHmd Biomedical, Inc.20121—
+3K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp.201112—
+4K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.20140—
+4K113547Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi…Apex BioTechnology Corp.20121—
+4K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp.20129—
+5K213887GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+5K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20150—
+5K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.20153—
+5K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.20143—
+6K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20172—
+6K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20162—
+7K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+7K202885GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20211—
+7K182992BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp.20180—
+8K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—