# K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Dec 19, 2003 after 242 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: 5 generations back to K945887 (1995). 15 ancestors in all.
18 later devices descend from it; 6 cite it directly.
2 of 34 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.
- K020866: Freestyle Tracker Diabetes Management System, Abbott Diabetes Care, Inc. (2002) Summary page 1.

## Most influential descendants
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own
- 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
- K060481: Liberty Glucose Control Solution (2006), 4 descendants of its own

## Indications for use
FreeStyle Blood Glucose Monitoring System The TheraSense, Inc., FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. FreeStyle Tracker Diabetes Management System The TheraSense, Inc., FreeStyle Tracker Diabetes Management System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program. The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

Source page: https://510kreport.com/device/K031260
Methodology: https://510kreport.com/methodology