Cleared Traditional

K040894 - QBTEST

K040894 · Qbtech AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
77d
Days
-
Risk

K040894 is an FDA 510(k) clearance for the QBTEST. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Qbtech AB (Goteborg, SE). The FDA issued a Cleared decision on June 22, 2004 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040894

510(k) Number K040894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2004
Decision Date June 22, 2004
Days to Decision 77 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
72d faster than avg
Panel avg: 149d · This submission: 77d
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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K040894 · QBTEST
Download PDF FDA Summary Qbtech AB