Cleared Special

K192787 - Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System (FDA 510(k) Clearance)

K192787 · Dexcom, Inc. · Chemistry device
Oct 2019
Decision
25d
Days
Class 2
Risk

K192787 is an FDA 510(k) clearance for the Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System. This device is classified as 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 October 25, 2019, 25 days after receiving the submission on September 30, 2019.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1355. 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..

Submission Details

510(k) Number K192787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date October 25, 2019
Days to Decision 25 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.