# K032985: Glucoleader Enhance Self-Monitoring of Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Hmd Biomedical, Inc.
- Decided: Oct 21, 2003 after 27 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 K023279 (2003). 1 ancestor in all.
7 later devices descend from it; 4 cite 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)
- K023279: Glucoleader Value, Hmd Biomedical, Inc. (2003)

## Most influential descendants
- 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
- K140150: Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System                            Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System                                  Goodlife AC-30 (2015), 0 descendants of its own

## Indications for use
The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K032985
Methodology: https://510kreport.com/methodology