BGM014 Blood Glucose Monitoring System
K-Number: K182992 · 2018-11-28
ApplicantApex BioTechnology Corp.
Decision Date2018-11-28
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
BGM014 Blood Glucose Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2018-11-28 under approval number K182992. 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 BGM014 Blood Glucose Monitoring System?
BGM014 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-11-28. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K182992.
When was BGM014 Blood Glucose Monitoring System approved by the FDA?
BGM014 Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-11-28, under approval number K182992.
What company makes BGM014 Blood Glucose Monitoring System?
BGM014 Blood Glucose Monitoring System is manufactured by Apex BioTechnology Corp..
What is the FDA product code for BGM014 Blood Glucose Monitoring System?
The FDA product code for BGM014 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07614139
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
COMPLETED
NCT06727942
Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
RECRUITING
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT07614100
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves
NOT_YET_RECRUITING
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 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
K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System
K202885GlucoSure HT Plus Blood Glucose Monitoring System
K222234GlucoSure ADVANCE Link 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.