Cleared Traditional

K201328 - Dexcom G6 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.

K201328 · Dexcom, Inc. · Chemistry device
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Jul 2021
Decision
422d
Days
Class 2
Risk

K201328 is an FDA 510(k) clearance for the Dexcom G6 Continuous Glucose Monitoring (CGM) 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 July 15, 2021 after a review of 422 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Dexcom, Inc. devices

Submission Details

510(k) Number K201328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2020
Decision Date July 15, 2021
Days to Decision 422 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
334d slower than avg
Panel avg: 88d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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