510(k) Report

Devices descending from K150214

4 later devices reach OneTouch Verio Flex Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH20201—
+1K173658Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC20180—
+1K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring…Tianjin Empecs Medical Device Co., Ltd.20170—
+2K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.20240—