Cleared Special

K221259 - Dexcom G6 Continuous Glucose Monitoring...

K221259 is the FDA 510(k) clearance for Dexcom G6 Continuous Glucose Monitoring... by Dexcom, Inc.. It is a Class 2 Chemistry device (product code QBJ) cleared through the Special 510(k) pathway after a 88-day FDA review.

K221259 · Dexcom, Inc. · Chemistry device
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Jul 2022
Decision
88d
Days
Class 2
Risk

K221259 is an FDA 510(k) clearance for the Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Progr.... 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 29, 2022 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. 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 K221259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date July 29, 2022
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 K221259.
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · Abbott Diabetes Care, Inc. · Mar 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · Dexcom, Inc. · Jan 2023
Dexcom G7 Continuous Glucose Monitoring System
K213919 · Dexcom, Inc. · Dec 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K201328 · Dexcom, Inc. · Jul 2021
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K200876 · Dexcom, Inc. · Dec 2020
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
K191450 · Dexcom, Inc. · Jun 2019