Cleared Traditional

K161222 - PENTAX MEDICAL ED-3490TK

K161222 is the FDA 510(k) clearance for PENTAX MEDICAL ED-3490TK by Pentax Medical. It is a Class 2 Gastroenterology & Urology device (product code FDT) cleared through the Traditional 510(k) pathway after a 649-day FDA review.

K161222 · Pentax Medical · Gastroenterology & Urology device
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Feb 2018
Decision
649d
Days
Class 2
Risk

K161222 is an FDA 510(k) clearance for the PENTAX MEDICAL ED-3490TK, 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 February 7, 2018 after a review of 649 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Pentax Medical devices

Submission Details

510(k) Number K161222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date February 07, 2018
Days to Decision 649 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
519d slower than avg
Panel avg: 130d · This submission: 649d
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 30
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K161222.
FUJIFILM Duodenoscope Model
K181745 · Fujifilm Corporation · Mar 2019
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
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