# K081726: Tysonbio Link Health Management System

- Pathway: 510(k) (Traditional)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Aug 26, 2008 after 69 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 K984527 (1999). 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)
- K984527: IN Touch Diabetes Management Software, Lifescan, Inc. (1999) Summary page 2.

## Indications for use
The TysonBio Link Health Management System is an optional software accessory for use with the following models with data management capabilities: a) EZ Smart-608 series meter, b) DIACHEX Series Blood Glucose Meter, and c) DIACHEX+ Series Blood Glucose Meter. When used with one of these meters, TysonBio Link Health Management System transfers data from the device's memory into a computer for enhanced data management. TysonBio Link Health Management System is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

Source page: https://510kreport.com/device/K081726
Methodology: https://510kreport.com/methodology