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FDA 510(k)

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

K-Number: K190805 · 2019-12-20

ApplicantPentax of America, Inc.
Decision Date2019-12-20
Product CodePEA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval number K190805. 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-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

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 is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Pentax of America, Inc.. The 510(k) number is K190805.

When was 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 approved by the FDA?

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 received FDA 510(k) clearance on 2019-12-20, under approval number K190805.

What company makes 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 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 is manufactured by Pentax of America, Inc..

What is the FDA product code for 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?

The FDA product code for 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 is PEA.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT07136506 Gait Analysis Parameter and Upper Limb Evaluation in Control Participants RECRUITING NCT07267689 Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children RECRUITING 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

Related PubMed Literature

PMID: 41264823 In vitro diagnostic devices need a robust regulatory framework. The New Zealand medical journal (2025) PMID: 40644609 Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance. JMIR medical informatics (2025) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 40206521 Embedding Internal Accountability Into Health Care Institutions for Safe, Effective, and Ethical Implementation of Artificial Intelligence Into Medical Practice: A Mayo Clinic Case Study. Mayo Clinic proceedings. Digital health (2024)

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

View all 39 devices →

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. 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. K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax 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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