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FDA 510(k)

GlucoLeader Enhance 2 Blood Glucose Monitoring System

K-Number: K212248 · 2022-08-29

ApplicantHmd Biomedical, Inc.
Decision Date2022-08-29
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GlucoLeader Enhance 2 Blood Glucose Monitoring System is a medical device manufactured by Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2022-08-29 under approval number K212248. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GlucoLeader Enhance 2 Blood Glucose Monitoring System?

GlucoLeader Enhance 2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-29. It is manufactured by Hmd Biomedical, Inc.. The 510(k) number is K212248.

When was GlucoLeader Enhance 2 Blood Glucose Monitoring System approved by the FDA?

GlucoLeader Enhance 2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-29, under approval number K212248.

What company makes GlucoLeader Enhance 2 Blood Glucose Monitoring System?

GlucoLeader Enhance 2 Blood Glucose Monitoring System is manufactured by Hmd Biomedical, Inc..

What is the FDA product code for GlucoLeader Enhance 2 Blood Glucose Monitoring System?

The FDA product code for GlucoLeader Enhance 2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Hmd Biomedical, Inc.

K182428GlucoLeader Enhance Blood Glucose Monitoring System

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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