Cleared Special

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. · Chemistry

Jun 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K191450 is an FDA 510(k) clearance for the Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System, a Integrated Continuous Glucose Monitoring System, Factory Calibrated (Class II — Special Controls, product code QBJ), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on June 28, 2019, 28 days after receiving the submission on May 31, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K191450 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2019
Decision Date	June 28, 2019
Days to Decision	28 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QBJ — Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class	Class II — 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.