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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 the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-06-03 under 510(k) 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. The listed applicant is Pentax of America, Inc.. The 510(k) number is K251127.

When did PENTAX Medical Video Processor (EPK-i8020c) receive FDA 510(k) clearance?

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

Who is the listed applicant for PENTAX Medical Video Processor (EPK-i8020c)?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Pentax of America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

View all 39 devices →

Related Devices (Code: PEA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax 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.K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, 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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