# K132511: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Dec 24, 2013 after 134 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: 8 generations back to K945887 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130094: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System, Abbott Diabetes Care (2013) Summary page 1.

## Most influential descendants
- K153330: FreeStyle Precision Neo H Blood Glucose Monitoring System (2016), 0 descendants of its own

## Indications for use
The Freestyle Precision Pro Blood Glucose and O-Ketone Monitoring System is intended fir the quantitative measurement of glucose (sugar) in flresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of P- ketone (beta-hydroxybutyrate) in flesh capillary whole blood from the finger and venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and O-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings assa 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. The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and 1-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn ftom the fingertips and from venous, arterial, and neonatal whole blood. The Freestyle Precision Pro Blood P-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and P-Ketone Meter to quantitatively measure 0-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial, and neonatal whole blood. Freestyle Precision Pro Blood Glucose and I)-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

Source page: https://510kreport.com/device/K132511
Methodology: https://510kreport.com/methodology