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FDA 510(k)

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System

K-Number: K261402 · 2026-06-08

ApplicantDexcom, Inc.
Decision Date2026-06-08
Product CodeQBJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2026-06-08 under 510(k) number K261402. 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 G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System?

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2026-06-08. The listed applicant is Dexcom, Inc.. The 510(k) number is K261402.

When did Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System receive FDA 510(k) clearance?

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System received FDA 510(k) clearance on 2026-06-08, under 510(k) number K261402.

Who is the listed applicant for Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System?

The FDA 510(k) record lists Dexcom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System?

The FDA product code for Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System is QBJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07603284Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi ArabiaACTIVE_NOT_RECRUITINGNCT07681024Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)NOT_YET_RECRUITINGNCT04386005Continuous Glucose Monitoring in At-Risk NewbornsCOMPLETEDNCT07422831T2D Intermittent Nonprescription Sensors for Informed Glucose Health TrackingENROLLING_BY_INVITATIONNCT07611721Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.RECRUITINGNCT07614139Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic DisordersCOMPLETED

Other records listing Dexcom, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260935Stelo Glucose Biosensor SystemK261359Stelo Glucose Biosensor SystemK253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemK253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemK252818Dexcom Smart BasalK243214Dexcom G7 15 Day Continuous Glucose Monitoring System

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Related Devices (Code: QBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.K234133Dexcom 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.

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