510(k) Report

Devices descending from K073648

13 later devices reach Glucosure Star Blood Glucose Monitoring System, Model AS90000E1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp.201112—
+2K113547Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi…Apex BioTechnology Corp.20121—
+2K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp.20129—
+3K213887GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+3K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20150—
+3K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.20153—
+3K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.20143—
+4K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20172—
+4K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20162—
+5K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+5K202885GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20211—
+5K182992BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp.20180—
+6K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—