Not Cleared Direct

DEN180067 - Mucosal Integrity Conductivity (MI) Test System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180067 · Diversatek Healthcare, Inc. · Gastroenterology & Urology device
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Dec 2019
Decision
371d
Days
Class 2
Risk

DEN180067 is an FDA 510(k) submission (not cleared) for the Mucosal Integrity Conductivity (MI) Test System. Classified as Esophageal, Mucosal, Electrical Characterization (product code QIS), Class II - Special Controls.

Submitted by Diversatek Healthcare, Inc. (Highlands Ranch, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2019 after a review of 371 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1450 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 371 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN180067 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 17, 2018
Decision Date December 23, 2019
Days to Decision 371 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 130d · This submission: 371d
Pathway characteristics

Device Classification

Product Code QIS Esophageal, Mucosal, Electrical Characterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1450
Definition The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue.
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 Gastroenterology & Urology devices follow this clearance model.