# K093819: Arkray Diabetes Data Management Software (SMBG Viewer)

- Pathway: 510(k) (Traditional)
- Applicant: Arkray Factory USA, Inc.
- Decided: Jun 9, 2010 after 177 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 K001907 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022545: Glucobalance Data Management Software, Model 555020, Hypoguard USA, Inc. (2002) Summary page 1.

## Indications for use
The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software 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. The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software 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/K093819
Methodology: https://510kreport.com/methodology