Cleared Traditional

K143468 - QbCheck

K143468 · Qbtech AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
474d
Days
-
Risk

K143468 is an FDA 510(k) clearance for the QbCheck. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Qbtech AB (Stockholm, SE). The FDA issued a Cleared decision on March 22, 2016 after a review of 474 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K143468

510(k) Number K143468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2014
Decision Date March 22, 2016
Days to Decision 474 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
325d slower than avg
Panel avg: 149d · This submission: 474d
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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Download PDF FDA Summary Qbtech AB