510(k) · Cleared

Cleared

QbCheck

K143468510(k) TraditionalCleared Mar 22, 2016474-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Qbtech AB · LQD Recorder, Attention Task Performance

Cleared on Mar 22, 2016 as substantially equivalent to K133382 (Qbtech AB, 2014) after a 474-day review. Its family tree reaches back 5 generations to 1986.

Decided: Mar 22, 2016
Review: 474 days
Class: Class U
Product code: LQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K854903 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK854903 Gordon Diagnostic System Model IClinical Diagnostics, Inc. · 1986
4 generations backK020800 Optax SystemOptax Systems, Inc. · 2002
3 generations backK040894 QbtestQbtech AB · 2004
2 generations backK122149 QBTESQbtech AB · 2012
1 generation backK133382 QB TestQbtech AB · 2014
This deviceK143468 QbCheckQbtech AB · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K854903	Gordon Diagnostic System Model I	Clinical Diagnostics, Inc.	1986	—
−4	K020800	Optax System	Optax Systems, Inc.	2002	—
−3	K040894	Qbtest	Qbtech AB	2004	—
−2	K122149	QBTES	Qbtech AB	2012	—
−1	K133382	QB Test	Qbtech AB	2014	—
0 (this device)	K143468	QbCheck	Qbtech AB	2016	—

FIG. 1 — Lineage of K143468, 1986–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K133382	QB Test Summary page 4 …[email protected] Trade Name: QbCheck Classification name: Recorder, attention task performance Product Code: LQD Predicate Device: QbTest (K133382) Device Description: QbCheck is a non-invasive test that has been developed to provide precise quantitative…	Qbtech AB	2014	—

Also cleared against K133382: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K133382.

How does its category compare?

All LQD devices

LQD Recorder, Attention Task Performance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · LQD

1in 2018

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQD

Too few LQD 510(k)s in any year since 2007 to give a median.

Recalls per year · LQD

No recall names LQD since 2007.

Adverse event reports per year · LQD

No MAUDE report names LQD since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	2	—	0
2015	0	—	0
2016	1	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

QbCheck provides health care professionals with objective measurements of hyperactivity, impulsivity, and inattention to

aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. QbCheck

results should be interpreted only by qualified health care professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143468: QbCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143468

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026