Submission Details
| 510(k) Number | K251127 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
PENTAX Medical Video Processor (EPK-i8020c)
Jun 2025
Decision
53d
Days
Class 2
Risk
About This 510(k) Submission
K251127 is an FDA 510(k) clearance for the PENTAX Medical Video Processor (EPK-i8020c), a Endoscope, Accessories, Image Post-processing For Color Enhancement (Class II — Special Controls, product code PEA), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on June 3, 2025, 53 days after receiving the submission on April 11, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | PEA — Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Device Class | Class II — 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. |
Manufacturer
Similar Devices — PEA Endoscope, Accessories, Image Post-processing For Color Enhancement
All 8
K231249 · Pentax of America, Inc.
· Jul 2023
K190805 · Pentax of America, Inc.
· Dec 2019
K191282 · Pentax of America, Inc.
· Nov 2019
K173679 · Pentax of America, Inc.
· Jul 2018
K160275 · Endochoice, Inc.
· Aug 2016
K150618 · Pentax of America, Inc.
· Nov 2015
More from Pentax of America, Inc.
View all
K251256
· FDS · Dec 2025
K242110
· FDF · Jan 2025
K241213
· FDS · Dec 2024
K233942
· FDT · Aug 2024
K240457
· GEH · Jul 2024