Cleared Traditional

K141164 - ARTEMIS LIGHT ENGINE (FDA 510(k) Clearance)

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

K141164 · Quest Medical Imaging · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
315d
Days
Class 2
Risk

K141164 is an FDA 510(k) clearance for the ARTEMIS LIGHT ENGINE. Classified as Led Light Source (product code NTN), Class II - Special Controls.

Submitted by Quest Medical Imaging (Akron, US). The FDA issued a Cleared decision on March 16, 2015 after a review of 315 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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K141164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2014
Decision Date March 16, 2015
Days to Decision 315 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
185d slower than avg
Panel avg: 130d · This submission: 315d
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.