# K002621: Glucosure Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Jan 22, 2001 after 152 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040678: Eusure Blood Glucose Monitoring System (2004), 1 descendant of its own
- K062892: Eukare (2007), 0 descendants of its own

## Recalls of this device
- Nov 16, 2007 · Not classified · Z-0699-2008: Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.

Source page: https://510kreport.com/device/K002621
Methodology: https://510kreport.com/methodology