# K040678: Eusure Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Eumed Biotechnology Co., Ltd.
- Decided: Jul 14, 2004 after 121 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: 1 generation back to K002621 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002621: Glucosure Blood Glucose Monitoring System, Apex BioTechnology Corp. (2001) Summary page 1.

## Most influential descendants
- K062892: Eukare (2007), 0 descendants of its own

## Indications for use
The EUSURE Blood Glucose Monitoring System is designed to measure the blood glucose levels in capillary whole blood. The system is suitable for diabetic patients to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients. The test range is from 30 mgldL to 600 mgldL ( 1.67 - 3.33 mmol/L).

Source page: https://510kreport.com/device/K040678
Methodology: https://510kreport.com/methodology