# K023279: Glucoleader Value

- Pathway: 510(k) (Traditional)
- Applicant: Hmd Biomedical, Inc.
- Decided: Aug 4, 2003 after 307 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032985: Glucoleader Enhance Self-Monitoring of Blood Glucose System (2003), 7 descendants of its own
- K182428: GlucoLeader Enhance Blood Glucose Monitoring System (2019), 1 descendant of its own
- K120064: Test, Blood Glucose System (2012), 1 descendant of its own
- K113307: GL Goodlife Series Blood Glucose Monitoring Sysmtem (2012), 1 descendant of its own
- K212248: GlucoLeader Enhance 2 Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
For the quantitative measurement of glucose levels in human capillary whole blood. For use in personal self monitoring and by health care workers in a professional setting.

Source page: https://510kreport.com/device/K023279
Methodology: https://510kreport.com/methodology