# K031843: Modification to Evencare Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Medline Industries, Inc.
- Decided: Jul 3, 2003 after 17 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EvenCare Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. It is intended for use outside the body by diabetics at home and in clinical settings as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K031843
Methodology: https://510kreport.com/methodology