# K153330: FreeStyle Precision Neo H Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Feb 19, 2016 after 92 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: 9 generations back to K945887 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132511: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System, Abbott Diabetes Care, Inc. (2013) Summary page 4.

## Indications for use
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood. The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing. The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.

Source page: https://510kreport.com/device/K153330
Methodology: https://510kreport.com/methodology