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FDA 510(k)

GlucoSure Link Blood Glucose Monitoring System

K-Number: K212140 · 2022-08-25

ApplicantApex BioTechnology Corp.
Decision Date2022-08-25
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GlucoSure Link Blood Glucose Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2022-08-25 under approval number K212140. 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 GlucoSure Link Blood Glucose Monitoring System?

GlucoSure Link Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K212140.

When was GlucoSure Link Blood Glucose Monitoring System approved by the FDA?

GlucoSure Link Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-25, under approval number K212140.

What company makes GlucoSure Link Blood Glucose Monitoring System?

GlucoSure Link Blood Glucose Monitoring System is manufactured by Apex BioTechnology Corp..

What is the FDA product code for GlucoSure Link Blood Glucose Monitoring System?

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Apex BioTechnology Corp.

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System K170267BGM009 Plus Blood Glucose Monitoring System K182593KET-1 Blood Ketone Monitoring System K182992BGM014 Blood Glucose Monitoring System K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System K202885GlucoSure HT Plus Blood Glucose Monitoring System

View all 12 devices →

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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