# K023584: Ascensia Dex 2 Diabetes Care System

- Pathway: 510(k) (Special)
- Applicant: Bayer Corp.
- Decided: Nov 20, 2002 after 26 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: 1 generation back to K020210 (2002). 1 ancestor in all.
2 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)
- K020210: Glucometer Dex Blood Glucose System (Modified), Bayer Group Diagnostics (2002)

## Most influential descendants
- 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 ASCENSIATMDEX82 Blood Glucose Meter is used with ASCENSIATMAUTODISCTMBlood Glucose Test Strips GLUCOMETER@ DEX8 Test Sensor and Controls for the measurement of glucose in whole blood. The ASCENSIATMDEX82 Diabetes Care System is an Over-The-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and 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/K023584
Methodology: https://510kreport.com/methodology