# K062770: Copilot Health Management System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Dec 14, 2006 after 90 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 K952279 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K040628: Precision Link Diabetes Data Management System, Abbott Laboratories (2004) Summary page 1.

## Most influential descendants
- 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 CoPilotTM Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.

Source page: https://510kreport.com/device/K062770
Methodology: https://510kreport.com/methodology