# K103115: Prodigy Diabetes Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Prodigy Diabetes Care, LLC
- Decided: Oct 12, 2011 after 356 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 K023219 (2002). 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)
- K023219: Becton Dickinson Diabetes Software, Becton, Dickinson & CO (2002) Summary page 1.

## Indications for use
The Prodigy® Diabetes Management Software is intended for use as a data management tool for acceptance, transfer, display, storage, processing (e.g. averaging), reporting and printing of patient blood glucose monitoring data. The device is intended for use with the Prodigy® Blood Glucose Monitoring Systems only.

Source page: https://510kreport.com/device/K103115
Methodology: https://510kreport.com/methodology