Cleared Traditional

K163614 - PENTAX Medical ED34-i10T

K163614 is the FDA 510(k) clearance for PENTAX Medical ED34-i10T by Pentax Medical. It is a Class 2 Gastroenterology & Urology device (product code FDT) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K163614 · Pentax Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
272d
Days
Class 2
Risk

K163614 is an FDA 510(k) clearance for the PENTAX Medical ED34-i10T, Video Duodenoscope. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Pentax Medical (Montvale, US). The FDA issued a Cleared decision on September 20, 2017 after a review of 272 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 Medical devices

Submission Details

510(k) Number K163614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2016
Decision Date September 20, 2017
Days to Decision 272 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 130d · This submission: 272d
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 31
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K163614.
FUJIFILM Duodenoscope Model
K182051 · Fujifilm Corporation · Oct 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
K181522 · Pentax of America, Inc. · Jul 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope
K161222 · Pentax Medical · Feb 2018
Fujifilm Duodenoscope Model ED-530XT
K152257 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2017
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
K143153 · Olympus Medical Systems Corp. · Jan 2016
CRE BALLOON DILATATION CATHETER
K110833 · Boston Scientific Corporation · Apr 2011