510(k) Report

Devices descending from K141036

3 later devices reach BGM009 Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20172—
+2K202885GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20211—
+3K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—