Cleared Special

Dexcom G7 Continuous Glucose Monitoring (CGM) System

K231081 · Dexcom, Inc. · Chemistry

May 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K231081 is an FDA 510(k) clearance for the Dexcom G7 Continuous Glucose Monitoring (CGM) 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 May 15, 2023, 28 days after receiving the submission on April 17, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K231081 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2023
Decision Date	May 15, 2023
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.