# K140371: Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT), Test Strips (100CT)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Sep 30, 2014 after 228 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: 1 generation back to K083223 (2009). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083223: Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count): 70973-01, Abbott Diabetes Care, Inc. (2009) Summary page 4.

## Most influential descendants
- K171941: FreeStyle Precision Neo Blood Glucose Test Strips (2017), 0 descendants of its own
- K142928: FreeStyle Precision Neo Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes. The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared. The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Source page: https://510kreport.com/device/K140371
Methodology: https://510kreport.com/methodology