Cleared Special

K203166 - PENTAX Medical Ultrasound Upper GI Vide...

K203166 is the FDA 510(k) clearance for PENTAX Medical Ultrasound Upper GI Vide... by Pentax of America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODG) cleared through the Special 510(k) pathway after a 68-day FDA review.

K203166 · Pentax of America, Inc. · Gastroenterology & Urology device
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Dec 2020
Decision
68d
Days
Class 2
Risk

K203166 is an FDA 510(k) clearance for the PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultr.... Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on December 30, 2020 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pentax of America, Inc. devices

Submission Details

510(k) Number K203166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2020
Decision Date December 30, 2020
Days to Decision 68 days
Submission Type Special
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
62d faster than avg
Panel avg: 130d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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 Consultant

Mic International
Fumiaki Kanai

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 36
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K203166.
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PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
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FUJIFILM Ultrasonic Endoscope
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K182004 · Pentax of America, Inc. · Aug 2018