Cleared Traditional

K122470 - PENTAX EPK-I5010 VIDEO PROCESSOR

K122470 is an FDA 510(k) clearance for PENTAX EPK-I5010 VIDEO PROCESSOR, manufactured by Pentax Medical. The device is a Class 2 Gastroenterology & Urology device with product code PEA cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K122470 · Pentax Medical · Gastroenterology & Urology device
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Apr 2013
Decision
240d
Days
Class 2
Risk

K122470 is an FDA 510(k) clearance for the PENTAX EPK-I5010 VIDEO PROCESSOR. Classified as Endoscope, Accessories, Image Post-processing For Color Enhancement (product code PEA), Class II - Special Controls.

Submitted by Pentax Medical (Montvale, US). The FDA issued a Cleared decision on April 10, 2013 after a review of 240 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 Pentax Medical devices

FDA 510(k) Submission Details - K122470

510(k) Number K122470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2012
Decision Date April 10, 2013
Days to Decision 240 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
109d slower than avg
Panel avg: 131d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PEA Endoscope, Accessories, Image Post-processing For Color Enhancement

All 8
Devices cleared under the same product code (PEA) and FDA review panel - the closest regulatory comparables to K122470.
Fuse Endoscopic System with FuseBox Processor
K160275 · Endochoice, Inc. · Aug 2016
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · Pentax of America, Inc. · Nov 2015
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2014