# K212248: GlucoLeader Enhance 2 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Hmd Biomedical, Inc.
- Decided: Aug 29, 2022 after 406 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: 3 generations back to K023279 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182428: GlucoLeader Enhance Blood Glucose Monitoring System, Hmd Biomedical, Inc. (2019) Summary page 4.

## Indications for use
The GlucoLeader Enhance 2 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 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 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 (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.

Source page: https://510kreport.com/device/K212248
Methodology: https://510kreport.com/methodology