Cleared Special

K253710 - Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253710 · Dexcom, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
23d
Days
Class 2
Risk

K253710 is an FDA 510(k) clearance for the Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Contin.... 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 December 17, 2025 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dexcom, Inc. devices

Submission Details

510(k) Number K253710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2025
Decision Date December 17, 2025
Days to Decision 23 days
Submission Type Special
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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 16
Devices cleared under the same product code (QBJ) and FDA review panel - the closest regulatory comparables to K253710.
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · Dexcom, Inc. · Feb 2026
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · Dexcom, Inc. · Apr 2025
FreeStyle Libre 3 Continuous Glucose Monitoring System
K233537 · Abbott Diabetes Care, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring System
K240902 · Dexcom, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring System
K234133 · Dexcom, Inc. · Feb 2024
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · Dexcom, Inc. · May 2023