Cleared Traditional

K180414 - EPX-4440FN Digital Video Processor with Light Source (FDA 510(k) Clearance)

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

K180414 · Fujifilm New Development U.S.A., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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

All 97
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K180414.
ProVee Video Processing Unit (PV-003)
K251734 · Proverum Limited · Sep 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K250462 · Univlabs Technologies Private Limited · Aug 2025
Endoscopic Camera System
K250204 · Shenzhen Sophway Technology Co., Ltd. · Jul 2025
FUJIFILM Processor EP-8000
K243260 · Fujifilm Corporation · Apr 2025
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
K242067 · Olympus Corporations of the Americas · Apr 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Feb 2025