# K963500: Glucometer Dex Diabetes Care System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jan 21, 1997 after 140 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 ELITE® Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) YSI Model 2300 STAT Plus Analyzer: named in the summary without a submission number
- (no number) ACA® Discrete Clinical Analyzer: named in the summary without a submission number
- (no number) Hitachi 704 chemistry analyzer: named in the summary without a submission number
- (no number) Hitachi 747 chemistry analyzer: named in the summary without a submission number

## Most influential descendants
- K060426: Liberty Glucose Normal Control Solutions, Model 2120041 (2006), 1 descendant of its own
- K080273: AB-Trol and Private Label Glucose Control Solution (2008), 0 descendants of its own

## Indications for use
The GLUCOMETER DEX Diabetes Care System is for the self- monitoring of blood glucose as an adjunct to the care of persons with diabetes.*

Source page: https://510kreport.com/device/K963500
Methodology: https://510kreport.com/methodology