Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dexcom G6 Continuous Glucose Monitoring (CGM) System

K-Number: K223931 · 2023-01-11

ApplicantDexcom, Inc.
Decision Date2023-01-11
Product CodeQBJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dexcom G6 Continuous Glucose Monitoring (CGM) System is a medical device manufactured by Dexcom, Inc.. It received FDA 510(k) clearance on 2023-01-11 under approval number K223931. The device is classified under product code QBJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dexcom G6 Continuous Glucose Monitoring (CGM) System?

Dexcom G6 Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Dexcom, Inc.. The 510(k) number is K223931.

When was Dexcom G6 Continuous Glucose Monitoring (CGM) System approved by the FDA?

Dexcom G6 Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2023-01-11, under approval number K223931.

What company makes Dexcom G6 Continuous Glucose Monitoring (CGM) System?

Dexcom G6 Continuous Glucose Monitoring (CGM) System is manufactured by Dexcom, Inc..

What is the FDA product code for Dexcom G6 Continuous Glucose Monitoring (CGM) System?

The FDA product code for Dexcom G6 Continuous Glucose Monitoring (CGM) System is QBJ.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING

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: 39670276 Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. Digital biomarkers (2024) 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 Dexcom, Inc.

K182405Dexcom Pro Q Continuous Glucose Monitoring System K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring System DEN170088Dexcom G6 Continuous Glucose Monitoring System K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System K191833Dexcom G6 Pro Continuous Glucose Monitoring System K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System

View all 23 devices →

Related Devices (Code: QBJ)

DEN170088Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc. K183206Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.

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.

↑