Cleared Traditional

K203089 - Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (FDA 510(k) Clearance)

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

K203089 · Dexcom, Inc. · Chemistry device
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Aug 2021
Decision
308d
Days
Class 2
Risk

K203089 is an FDA 510(k) clearance for the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) 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 August 17, 2021 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K203089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date August 17, 2021
Days to Decision 308 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
220d slower than avg
Panel avg: 88d · This submission: 308d
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.