Cleared Traditional

K233942 - PENTAX Medical Video Duodenoscope (ED34-i10T2s) (FDA 510(k) Clearance)

Also includes:
PENTAX Medical Video Processor (EPK-i8020c) PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63) Gas/Water Feeding Valves (OF-B194 )

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233942 · Pentax of America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
231d
Days
Class 2
Risk

K233942 is an FDA 510(k) clearance for the PENTAX Medical Video Duodenoscope (ED34-i10T2s). Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 231 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentax of America, Inc. devices

Submission Details

510(k) Number K233942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date August 01, 2024
Days to Decision 231 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 130d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDT Duodenoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDT Duodenoscope And Accessories, Flexible/rigid

All 34
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K233942.
FUJIFILM Endoscope Model ED-S100TP
K251861 · Fujifilm Corporation · Mar 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · Olympus Medical Systems Corp. · Feb 2026
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
K251867 · Olympus Medical Systems Corp. · Sep 2025
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
K250701 · Olympus Medical Systems Corp. · Jun 2025
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
K233886 · Ambu A/S · Apr 2024
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · Olympus Medical Systems Corp. · May 2022