# K070850: Freestyle Lite Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Apr 10, 2007 after 13 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: 8 generations back to K945887 (1995). 28 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001, Abbott Diabetes Care, Inc. (2006) Summary page 1.

## Most influential descendants
- K092602: FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (2010), 2 descendants of its own
- 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
- K083225: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System (2009), 0 descendants of its own

## Recalls of this device
- Jun 10, 2009 · Not classified · Z-1936-2009: Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood

## Indications for use
The FreeStyle TM Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand. The FreeStyle TM Lite 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/K070850
Methodology: https://510kreport.com/methodology