# K022545: Glucobalance Data Management Software, Model 555020

- Pathway: 510(k) (Traditional)
- Applicant: Hypoguard USA, Inc.
- Decided: Oct 11, 2002 after 71 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 K001907 (2000). 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)
- K001907: Camit Diabetes Management Software, Roche Diagnostics Corp. (2000)

## Most influential descendants
- K093819: Arkray Diabetes Data Management Software (SMBG Viewer) (2010), 0 descendants of its own

## Indications for use
Intended Use: GlucoBalanceTM Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

Source page: https://510kreport.com/device/K022545
Methodology: https://510kreport.com/methodology