# K122181: Ebchek Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Visgeneer, Inc.
- Decided: Aug 15, 2013 after 388 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K043197 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062555: Ebsensor Blood Glucose Monitoring System, Model EB-G, Visgeneer, Inc. (2006) Summary page 2.

## Indications for use
The eBchek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The eBchek Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The eBchek Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBehek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired. eBchek Blood Glucose Test Strips are for use with the eBchek Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. eB-series Control Solutions are for use with the eBehek Blood Glucose Meter and cechek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K122181
Methodology: https://510kreport.com/methodology