# K120558: Onetouch Reveal Diabetes Management Application

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Feb 7, 2013 after 349 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: 3 generations back to K001907 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1, Welldoc, Inc. (2010) Summary page 2.

## Indications for use
The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols

Source page: https://510kreport.com/device/K120558
Methodology: https://510kreport.com/methodology