Cleared Traditional

K182041 - Dexcom G6 Glucose Program Continuous Glucose Monitoring System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182041 · Dexcom, Inc. · Chemistry device
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Oct 2018
Decision
88d
Days
Class 2
Risk

K182041 is an FDA 510(k) clearance for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management (product code QDK), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on October 26, 2018 after a review of 88 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

Submission Details

510(k) Number K182041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date October 26, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDK Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1355
Definition An Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management Is Intended To Replace Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes Who Do Not Have Significant Risk Of Severe Hypoglycemia. The Device Also Aids In The Detection Of Episodes Of Hyperglycemia And Hypoglycemia, Facilitating Long-term Therapy Adjustments. The Device Is Also Intended To Autonomously Communicate With Digitally Connected Devices. The Device Can Be Used Alone Or In Conjunction With These Digitally Connected Devices Or Services For The Purpose Of Managing Diabetes.
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.