Cleared Traditional

K180414 - EPX-4440FN Digital Video Processor with...

K180414 is an FDA 510(k) clearance for EPX-4440FN Digital Video Processor with..., manufactured by Fujifilm New Development U.S.A., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K180414 · Fujifilm New Development U.S.A., Inc. · Gastroenterology & Urology device
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May 2018
Decision
98d
Days
Class 2
Risk

K180414 is an FDA 510(k) clearance for the EPX-4440FN Digital Video Processor with Light Source. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Fujifilm New Development U.S.A., Inc. (Waltham, US). The FDA issued a Cleared decision on May 24, 2018 after a review of 98 days - within the typical 510(k) review window.

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 New Development U.S.A., Inc. devices

FDA 510(k) Submission Details - K180414

510(k) Number K180414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2018
Decision Date May 24, 2018
Days to Decision 98 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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.

Regulatory Consultant

O'Connell Regulatory Consultants, Inc.
Maureen O'Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 61
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