Cleared Traditional

K201408 - Demetra Analytics Toolkit (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201408 · Barco N.V. · General & Plastic Surgery device
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Feb 2021
Decision
266d
Days
Class 2
Risk

K201408 is an FDA 510(k) clearance for the Demetra Analytics Toolkit. Classified as Light Based Imaging (product code PSN), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on February 18, 2021 after a review of 266 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Barco N.V. devices

Submission Details

510(k) Number K201408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2020
Decision Date February 18, 2021
Days to Decision 266 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 114d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSN Light Based Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
Definition Emission And Collection Of Light To Create An Image For Medical Purposes
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 General & Plastic Surgery devices follow this clearance model.