# K073118: Prodigy Voice Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Devices, Inc.
- Decided: Mar 5, 2008 after 121 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 K042005 (2004). 2 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060467: Prodigy Blood Glucose Test System, Diagnostic Devices, Inc. (2006) Summary page 1.

## Most influential descendants
- K091815: Supercheck 1 Blood Glucose Monitoring System, Model 6268 (2009), 6 descendants of its own
- K122338: Preferred Blood Glucose Monitoring System (2013), 3 descendants of its own
- K141914: Prodigy Autocode Eject Blood Glucose Monitoring System (2015), 1 descendant of its own
- K100560: Easy Talk Blood Glucose Monitoring System Model: 6277 (2010), 1 descendant of its own
- K093764: SOLOV2 Blood Glucose Monitoring System (2010), 1 descendant of its own

## Indications for use
The Prodigy Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in this system can be used only during steady-state blood glucose conditions. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Source page: https://510kreport.com/device/K073118
Methodology: https://510kreport.com/methodology