# K012205: Glucometer Dex Test Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 12, 2001 after 58 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The GLUCOMETER® DEX® TEST SENSOR is used with the GLUCOMETER® DEX® and GLUCOMETER® DEX®2 Blood Glucose Meters to measure the glucose level in whole blood. The GLUCOMETER® DEX Blood Glucose System is a home use (OTC) device used by persons with diabetes, and by health care professionals in clinical settings for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K012205
Methodology: https://510kreport.com/methodology