Cleared Traditional

K261402 - Dexcom G7 Continuous Glucose Monitoring...

Also marketed or referenced as:
Dexcom G7 15 Day Continuous Glucose Monitoring System

K261402 is an FDA 510(k) clearance for Dexcom G7 Continuous Glucose Monitoring..., manufactured by Dexcom, Inc.. The device is a Class 2 Chemistry device with product code QBJ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K261402 · Dexcom, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
40d
Days
Class 2
Risk

K261402 is an FDA 510(k) clearance for the Dexcom G7 Continuous Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on June 8, 2026 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexcom, Inc. devices

FDA 510(k) Submission Details - K261402

510(k) Number K261402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2026
Decision Date June 08, 2026
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QBJ Device Classification - Class 2, Special Controls

Product Code QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1355
Definition An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated

All 17
Devices cleared under the same product code (QBJ) and FDA review panel - the closest regulatory comparables to K261402.
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · Dexcom, Inc. · Feb 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
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Dexcom G7 15 Day Continuous Glucose Monitoring System
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K240902 · Dexcom, Inc. · Apr 2024
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K234133 · Dexcom, Inc. · Feb 2024