# K091229: Glucomanager Data Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Eps Bio Technology Corp.
- Decided: Jul 31, 2009 after 95 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 K984527 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984527: IN Touch Diabetes Management Software, Lifescan, Inc. (1999) Summary page 3.

## Indications for use
The GlucoManager Data Management Software (GDMS) is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. The device is not intended to provide any diagnosis based upon patient results.

Source page: https://510kreport.com/device/K091229
Methodology: https://510kreport.com/methodology