Cleared Traditional

K150618 - PENTAX Medical EPK-i7010 Video Processor with GI Family

K150618 is an FDA 510(k) clearance for PENTAX Medical EPK-i7010 Video Processo..., manufactured by Pentax of America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PEA cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K150618 · Pentax of America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 2015
Decision
259d
Days
Class 2
Risk

K150618 is an FDA 510(k) clearance for the PENTAX Medical EPK-i7010 Video Processor with GI Family. Classified as Endoscope, Accessories, Image Post-processing For Color Enhancement (product code PEA), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on November 24, 2015 after a review of 259 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 of America, Inc. devices

FDA 510(k) Submission Details - K150618

510(k) Number K150618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date November 24, 2015
Days to Decision 259 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
128d slower than avg
Panel avg: 131d · This submission: 259d
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 K150618.
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
K191282 · Pentax of America, Inc. · Nov 2019
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173679 · Pentax of America, Inc. · Jul 2018
Fuse Endoscopic System with FuseBox Processor
K160275 · Endochoice, Inc. · Aug 2016
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2014
PENTAX EPK-I5010 VIDEO PROCESSOR
K122470 · Pentax Medical · Apr 2013