Cleared Traditional

K961568 - ED-344OT

K961568 is the FDA 510(k) clearance for ED-344OT by Pentax Precision Instrument Corp.. It is a Class 2 Gastroenterology & Urology device (product code FDT) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961568 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
77d
Days
Class 2
Risk

K961568 is an FDA 510(k) clearance for the ED-344OT. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on July 9, 1996 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K961568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1996
Decision Date July 09, 1996
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
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 K961568.
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
K980465 · Olympus America, Inc. · Apr 1998
KARL STORZ FRIMBERGER VARIOGUIDE
K962212 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
ED-3410, VIDEO DUODENOSCOPE
K963056 · Pentax Precision Instrument Corp. · Oct 1996
OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
K942338 · Olympus Corp. · Nov 1994
PENTAX FD-34A DUODENOFIBERSCOPE
K832006 · Pentax Precision Instrument Corp. · Aug 1983