510(k) Report

Devices descending from K131363

6 later devices reach Onetouch Verio Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemLifescan Europe20150—
+1K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe20154—
+2K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH20201—
+2K173658Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC20180—
+2K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring…Tianjin Empecs Medical Device Co., Ltd.20170—
+3K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.20240—