Cleared Traditional

VIDEO SYSTEM CENTER (K122831) - FDA 510(k) Clearance

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

K122831 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Dec 2012
Decision
88d
Days
Class 2
Risk

K122831 is an FDA 510(k) clearance for the VIDEO SYSTEM CENTER. Classified as Led Light Source (product code NTN), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 88 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 K122831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2012
Decision Date December 14, 2012
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTN Led Light Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals
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.