# K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Mar 9, 2006 after 245 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (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.
10 later devices descend from it; 3 cite it directly.
2 of 38 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 2.
- K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001, Abbott Diabetes Care, Inc. (2000) Summary page 2.
- K012014: Modification to Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2001) Summary page 2.
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005, Abbott Diabetes Care, Inc. (2003) Summary page 2.
- K050500: Freestyle 600 Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K122435: Nova One Blood Glucose Monitor (2012), 1 descendant of its own

## Recalls of this device
- Mar 13, 2009 · Not classified · Z-1258-2011: Product dispositioned for destruction was potentially diverted to end users.
- May 22, 2006 · Not classified · Z-1307-06: The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid

## Indications for use
The FreeStyle FreedomTM Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand. The FreeStyle FreedomTM 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 a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Source page: https://510kreport.com/device/K051839
Methodology: https://510kreport.com/methodology