Cleared Traditional

K251127 - PENTAX Medical Video Processor (EPK-i8020c) (FDA 510(k) Clearance)

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

K251127 · Pentax of America, Inc. · Gastroenterology & Urology device
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Jun 2025
Decision
53d
Days
Class 2
Risk

K251127 is an FDA 510(k) clearance for the PENTAX Medical Video Processor (EPK-i8020c). 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 June 3, 2025 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pentax of America, Inc. devices

Submission Details

510(k) Number K251127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2025
Decision Date June 03, 2025
Days to Decision 53 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
77d faster than avg
Panel avg: 130d · This submission: 53d
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.