# K150531: FreeStyle Freedom Lite Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jun 5, 2015 after 95 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: 10 generations back to K945887 (1995). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092602: FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2010) Summary page 4.

## Indications for use
The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Freedom Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Freedom Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.

Source page: https://510kreport.com/device/K150531
Methodology: https://510kreport.com/methodology