FDA Product Code PEA: Endoscope, Accessories, Image Post-processing For Color Enhancement
Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.
Leading manufacturers include Pentax of America, Inc. and Fujifilm Medical Systems U.S.A, Inc..
9
Total
9
Cleared
188d
Avg days
2013
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
53d
recently vs 205d historically
FDA 510(k) Cleared Endoscope, Accessories, Image Post-processing For Color Enhancement Devices (Product Code PEA)
9 devices
Cleared
Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
Pentax of America, Inc.
Gastroenterology & Urology
53d
Cleared
Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
Pentax of America, Inc.
Gastroenterology & Urology
88d
Cleared
Dec 20, 2019
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
Pentax of America, Inc.
Gastroenterology & Urology
266d
Cleared
Nov 08, 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
Pentax of America, Inc.
Gastroenterology & Urology
179d
Cleared
Jul 03, 2018
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
Pentax of America, Inc.
Gastroenterology & Urology
214d
Cleared
Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
Pentax of America, Inc.
Gastroenterology & Urology
259d
Cleared
Aug 22, 2014
EPX-4440HD DIGITAL VIDEO PROCESSOR
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology
212d
About Product Code PEA - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PEA since 2013, with 9 receiving FDA clearance (average review time: 188 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - PEA Product Code
Recent submissions under PEA have taken an average of 53 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
PEA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →