# K091765: Ebcarryon Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Visgeneer, Inc.
- Decided: Jan 19, 2010 after 216 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 1.

## Indications for use
The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K091765
Methodology: https://510kreport.com/methodology