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FDA 510(k)

PENTAX Medical Video Processor (EPK-i8020c)

K-Number: K251127 · 2025-06-03

ApplicantPentax of America, Inc.
Decision Date2025-06-03
Product CodePEA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Processor (EPK-i8020c) is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-06-03 under approval number K251127. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Video Processor (EPK-i8020c)?

PENTAX Medical Video Processor (EPK-i8020c) is a medical device that received FDA 510(k) clearance on 2025-06-03. It is manufactured by Pentax of America, Inc.. The 510(k) number is K251127.

When was PENTAX Medical Video Processor (EPK-i8020c) approved by the FDA?

PENTAX Medical Video Processor (EPK-i8020c) received FDA 510(k) clearance on 2025-06-03, under approval number K251127.

What company makes PENTAX Medical Video Processor (EPK-i8020c)?

PENTAX Medical Video Processor (EPK-i8020c) is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Video Processor (EPK-i8020c)?

The FDA product code for PENTAX Medical Video Processor (EPK-i8020c) is PEA.

Related Clinical Trials

NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07530731 Platforms Comparison Study - NIXOS-COMPARISON ENROLLING_BY_INVITATION NCT07568093 PARO-agitation-study RECRUITING NCT07280065 REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool RECRUITING NCT06473558 Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Pentax of America, Inc.

K162151PENTAX Medical ENT Video Imaging System K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner K182004PENTAX Medical Endoscopic Ultrasound System K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

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Related Devices (Code: PEA)

K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc. K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPentax of America, Inc. K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc. K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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