Cleared Traditional

K131902 - PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)

K131902 is an FDA 510(k) clearance for PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY), manufactured by Pentax Medical Company. The device is a Class 2 Gastroenterology & Urology device with product code FDS cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K131902 · Pentax Medical Company · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
289d
Days
Class 2
Risk

K131902 is an FDA 510(k) clearance for the PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY). Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Pentax Medical Company (Montvale, US). The FDA issued a Cleared decision on April 10, 2014 after a review of 289 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 Company devices

FDA 510(k) Submission Details - K131902

510(k) Number K131902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date April 10, 2014
Days to Decision 289 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
159d slower than avg
Panel avg: 130d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDS Device Classification - Class 2, Special Controls

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. 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 Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 65
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K131902.
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · Fujifilm Medical System U.S.A., Inc. · Mar 2016
Fuse Gastroscopy System
K152182 · Endochoice, Inc. · Dec 2015
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · Fujifilm Medical System U.S.A., Inc. · May 2015
PEERSCOPE SYSTEM
K131422 · Endochoice, Inc. · Oct 2013
FOREIGN BODY HOOD
K130148 · United States Endoscopy Group, Inc. · Aug 2013
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
K123317 · Olympus Medical Systems Corporation · Dec 2012