Cleared Special

K210710 - PENTAX Medical Video Duedenoscope ED34-...

K210710 is an FDA 510(k) clearance for PENTAX Medical Video Duedenoscope ED34-..., manufactured by Pentax of America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDT cleared through the Special 510(k) pathway after a 30-day FDA review.

K210710 · Pentax of America, Inc. · Gastroenterology & Urology device
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Apr 2021
Decision
30d
Days
Class 2
Risk

K210710 is an FDA 510(k) clearance for the PENTAX Medical Video Duedenoscope ED34-i10T2. 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 April 9, 2021 after a review of 30 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

FDA 510(k) Submission Details - K210710

510(k) Number K210710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2021
Decision Date April 09, 2021
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

FDT Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K210710.
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · Pentax of America, Inc. · Aug 2024
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
Pentax Medical Video Duodenoscope ED32-i10
K202365 · Pentax of America, Inc. · Apr 2021
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K202661 · Olympus Medical Systems Corp. · Dec 2020
FUJIFILM Distal End Cap
K203028 · Fujifilm Corporation · Oct 2020