# K020210: Glucometer Dex Blood Glucose System (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Group Diagnostics
- Decided: Apr 30, 2002 after 98 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.
3 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) GLUCOMETER® DEX® Blood Glucose Meter: named in the summary without a submission number
- (no number) GLUCOMETER® DEX® Test Sensors: named in the summary without a submission number

## Most influential descendants
- K023584: Ascensia Dex 2 Diabetes Care System (2002), 2 descendants of its own
- K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002 (2008), 1 descendant of its own
- K123966: Glucose Meter-Check Solution for Bayer (2013), 0 descendants of its own

## Indications for use
The GLUCOMETER® DEX® 2 Blood Glucose Meter and the GLUCOMETER® DEX® Test Sensors are used to measure the glucose levels in whole blood from specimens taken from the fingers or an alternate puncture sites within certain conditions. The GLUCOMETER® DEX® Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K020210
Methodology: https://510kreport.com/methodology