# K182428: GlucoLeader Enhance Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hmd Biomedical, Inc.
- Decided: May 8, 2019 after 244 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: 2 generations back to K023279 (2003). 2 ancestors in all.
1 later device descends 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)
- K032985: Glucoleader Enhance Self-Monitoring of Blood Glucose System, Hmd Biomedical, Inc. (2003) Summary page 4.

## Most influential descendants
- K212248: GlucoLeader Enhance 2 Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.

Source page: https://510kreport.com/device/K182428
Methodology: https://510kreport.com/methodology