# K120568: Freestyle Insulinx Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Mar 29, 2012 after 31 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945887 (1995). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111874: Freestyle Insulinx Blood Glucose Monitoring Systems, Abbott Laboratories (2012) Summary page 5.

## Most influential descendants
- K152328: FreeStyle InsuLinx Blood Glucose Monotioring System (2015), 0 descendants of its own

## Recalls of this device
- Apr 15, 2013 · Class I · Z-1245-2013: AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

## Indications for use
The FreeStyle InsuL-inx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The FreeStyle InsuLinx 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 to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The FreeStyle lnsuLinx Blood Glucose Test Strips are for use with the FreeStyle lnsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

Source page: https://510kreport.com/device/K120568
Methodology: https://510kreport.com/methodology