Cleared Traditional

K141865 - DANA (FDA 510(k) Clearance)

K141865 · Anthrotronix, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2014
Decision
97d
Days
-
Risk

K141865 is an FDA 510(k) clearance for the DANA. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Anthrotronix, Inc. (Silver Spring, US). The FDA issued a Cleared decision on October 15, 2014 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Anthrotronix, Inc. devices

Submission Details

510(k) Number K141865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2014
Decision Date October 15, 2014
Days to Decision 97 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 148d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -