Cleared Traditional

K122149 - QBTES

K122149 · Qbtech AB · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2012
Decision
90d
Days
-
Risk

K122149 is an FDA 510(k) clearance for the QBTES. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Qbtech AB (Stockholm, SE). The FDA issued a Cleared decision on October 17, 2012 after a review of 90 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.

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FDA 510(k) Submission Details - K122149

510(k) Number K122149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2012
Decision Date October 17, 2012
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LQD Device Classification - Class 0,

Product Code LQD Recorder, Attention Task Performance
Device Class -