# K031501: Easygluco, Model IGM0002

- Pathway: 510(k) (Traditional)
- Applicant: American Healthcare, Inc.
- Decided: Oct 16, 2003 after 156 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 K942455 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003)
- K984261: Surestep Blood Glucose Monitoring System, Lifescan, Inc. (1999) Summary page 2.
- K021513: Accu-Chek Advantage Module, Roche Diagnostics Corp. (2002)

## Indications for use
The EASYGLUCOTMMonitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Source page: https://510kreport.com/device/K031501
Methodology: https://510kreport.com/methodology