# K040628: Precision Link Diabetes Data Management System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Mar 25, 2004 after 15 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 K952279 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952279: Precision Link Blood Glucose Data Management System, Medisense, Inc. (1995) Summary page 1.

## Most influential descendants
- K062770: Copilot Health Management System (2006), 3 descendants of its own
- K102063: Health-E-Connect System (2011), 1 descendant of its own
- K163664: Health-e-Connect System with IDA (2017), 0 descendants of its own
- K123089: Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001 (2013), 0 descendants of its own

## Indications for use
The MediSense Precision Link® Diabetes Data Management System lets you view and analyze results of a MediSense Products meter. It enables the users to upload blood glucose and blood ketone results from a MediSense Products meter, view the information, and print the information using various report formats. Precision Link is designed for use by people with diabetes and/or healthcare professionals that have a basic understanding of personal computers

Source page: https://510kreport.com/device/K040628
Methodology: https://510kreport.com/methodology