Cleared Traditional

K182405 - Dexcom Pro Q Continuous Glucose Monitoring System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182405 · Dexcom, Inc. · Chemistry device
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Nov 2018
Decision
59d
Days
Class 2
Risk

K182405 is an FDA 510(k) clearance for the Dexcom Pro Q Continuous Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System For Professional Retrospective Use (product code QDL), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexcom, Inc. devices

Submission Details

510(k) Number K182405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDL Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.