Cleared Traditional

K140149 - EPX-4440HD DIGITAL VIDEO PROCESSOR (FDA 510(k) Clearance)

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

K140149 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
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Aug 2014
Decision
212d
Days
Class 2
Risk

K140149 is an FDA 510(k) clearance for the EPX-4440HD DIGITAL VIDEO PROCESSOR. Classified as Endoscope, Accessories, Image Post-processing For Color Enhancement (product code PEA), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 212 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K140149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date August 22, 2014
Days to Decision 212 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 130d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEA Endoscope, Accessories, Image Post-processing For Color Enhancement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.
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.