Atlas FDA

PEA

9 FDA 510(k) clearances · Product code

212 daysmedian time to decision
266 days90th percentile
9clearances measured

FDA profile

Official device name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Adverse events (MAUDE)
2021: 201 · 2022: 66 · 2023: 78 · 2024: 103 · 2025: 61 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PENTAX Medical Video Processor (EPK-i8020c) (K251127)Pentax of America, Inc.2025-06-03
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (K231249)Pentax of America, Inc.2023-07-28
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 (K190805)Pentax of America, Inc.2019-12-20
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282)Pentax of America, Inc.2019-11-08
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679)Pentax of America, Inc.2018-07-03
Fuse Endoscopic System with FuseBox Processor (K160275)Endochoice, Inc.2016-08-01
PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618)Pentax of America, Inc.2015-11-24
EPX-4440HD DIGITAL VIDEO PROCESSOR (K140149)Fujifilm Medical Systems U.S.A, Inc.2014-08-22
PENTAX EPK-I5010 VIDEO PROCESSOR (K122470)Pentax Medical2013-04-10

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Every clearance here is in the API, with alerts when new ones post.