Not Cleared Post-NSE

DEN100016 - PROSTATE MECHANICAL IMAGER (FDA 510(k) Clearance)

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

DEN100016 · Artann Laboratories, Inc. · Gastroenterology & Urology device
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Apr 2012
Decision
707d
Days
Class 2
Risk

DEN100016 is an FDA 510(k) submission (not cleared) for the PROSTATE MECHANICAL IMAGER. Classified as Prostate Lesion, Documentation, System (product code OQT), Class II - Special Controls.

Submitted by Artann Laboratories, Inc. (Washington D.C., US). The FDA issued a Not Cleared (DENG) decision on April 27, 2012 after a review of 707 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.2050 - 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 707 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.

View all Artann Laboratories, Inc. devices

Submission Details

510(k) Number DEN100016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 21, 2010
Decision Date April 27, 2012
Days to Decision 707 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
577d slower than avg
Panel avg: 130d · This submission: 707d
Pathway characteristics

Device Classification

Product Code OQT Prostate Lesion, Documentation, System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.2050
Definition Produces An Elasticity Image Of The Prostate To Document Prostate Abnormalities That Were Previously Identified By Digital Rectal Examination.
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.