Cleared Traditional

K141865 - DANA

K141865 · Anthrotronix, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K141865

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 149d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

LQD Device Classification - Class 0,

Product Code LQD Recorder, Attention Task Performance
Device Class -

Regulatory Peers - LQD Recorder, Attention Task Performance

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K141865 · DANA
Download PDF FDA Summary Anthrotronix, Inc.