# K051802: Freestyle Connect Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Aug 9, 2005 after 35 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945887 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022941: Medisense Precision PCX Point of Care Management System for Blood Glucose Testing, Abbott Laboratories (2002) Summary page 2.
- K050500: Freestyle 600 Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2005) Summary page 2.

## Recalls of this device
- Feb 17, 2006 · Not classified · Z-0604-06: The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.

## Indications for use
The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Source page: https://510kreport.com/device/K051802
Methodology: https://510kreport.com/methodology