# K092602: FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: May 14, 2010 after 262 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945887 (1995). 29 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070850: Freestyle Lite Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2007) Summary page 1.

## Most influential descendants
- K150332: FreeStyle Lite Blood Glucose Monitoring System (2015), 0 descendants of its own
- K150531: FreeStyle Freedom Lite Blood Glucose Monitoring System (2015), 0 descendants of its own

## Recalls of this device
- Nov 18, 2013 · Class I · Z-0486-2014: Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and
- Nov 18, 2013 · Class I · Z-0485-2014: Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and

## Indications for use
The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm; and venous 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. The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm; and venous 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/K092602
Methodology: https://510kreport.com/methodology