Cleared Traditional

AUTOMATED ENDOSCOPE LEAK TESTER (K123704) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123704 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Feb 2013
Decision
63d
Days
Class 2
Risk

K123704 is an FDA 510(k) clearance for the AUTOMATED ENDOSCOPE LEAK TESTER. Classified as Endoscopic Leak Tester (product code PCV), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on February 4, 2013 after a review of 63 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K123704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date February 04, 2013
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCV Endoscopic Leak Tester
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition An Endoscopic Leak Tester Automatically Detects Leaks From Endoscopes, Without Requiring Visual Observation For Bubbles When The Device Is Immersed In Water, By Assessing Differences In Air Pressure Inside The Pressurized Endoscope.
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.