# K050500: Freestyle 600 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Jun 27, 2005 after 119 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: 6 generations back to K945887 (1995). 26 ancestors in all.
12 later devices descend from it; 2 cite it directly.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992684: Freestyle Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2000) Summary page 1.
- K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001, Abbott Diabetes Care, Inc. (2000) Summary page 1.
- K012014: Modification to Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2001) Summary page 1.
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005, Abbott Diabetes Care, Inc. (2003) Summary page 1.
- K022941: Medisense Precision PCX Point of Care Management System for Blood Glucose Testing, Abbott Laboratories (2002) Summary page 1.

## Most influential descendants
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001 (2006), 10 descendants of its own
- K092638: Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23 (2010), 4 descendants of its own
- K070850: Freestyle Lite Blood Glucose Monitoring System (2007), 4 descendants of its own
- K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips (2012), 3 descendants of its own
- K092602: FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (2010), 2 descendants of its own

## Indications for use
The FreeStyle 600 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 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 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/K050500
Methodology: https://510kreport.com/methodology