Cleared Traditional

Dexcom Pro Q Continuous Glucose Monitoring System

K182405 · Dexcom, Inc. · Chemistry

Nov 2018

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K182405 is an FDA 510(k) clearance for the Dexcom Pro Q Continuous Glucose Monitoring System, a Integrated Continuous Glucose Monitoring System For Professional Retrospective Use (Class II — Special Controls, product code QDL), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on November 2, 2018, 59 days after receiving the submission on September 4, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K182405 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2018
Decision Date	November 02, 2018
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QDL — Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1355
Definition	An Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Is A Continuous Glucose Recording Device Indicated For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older For Use By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices.