Cleared Special

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

K193642 · Dexcom, Inc. · Chemistry

Jan 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K193642 is an FDA 510(k) clearance for the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, a Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management (Class II — Special Controls, product code QDK), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on January 29, 2020, 30 days after receiving the submission on December 30, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K193642 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2019
Decision Date	January 29, 2020
Days to Decision	30 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QDK — Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management
Device Class	Class II — 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.