510(k) · Cleared
ClearedQB Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qbtech AB · LQD Recorder, Attention Task Performance
Cleared on Mar 24, 2014 as substantially equivalent to K122149 (Qbtech AB, 2012) after a 140-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Mar 24, 2014
- Review
- 140 days
- Class
- Class U
- Product code
- LQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854903 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK854903 Gordon Diagnostic System Model IClinical Diagnostics, Inc. · 1986
- 3 generations backK020800 Optax SystemOptax Systems, Inc. · 2002
- 2 generations backK040894 QbtestQbtech AB · 2004
- 1 generation backK122149 QBTESQbtech AB · 2012
- This deviceK133382 QB TestQbtech AB · 2014
- Descendant · cites it directly · 0 of its ownK173915 Test of Variables of Attention (T.O.V.A.)The Tova Company · 2018
- Descendant · cites it directly · 0 of its ownK143468 QbCheckQbtech AB · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854903 | Gordon Diagnostic System Model I | Clinical Diagnostics, Inc. | 1986 | — |
| −3 | K020800 | Optax System | Optax Systems, Inc. | 2002 | — |
| −2 | K040894 | Qbtest | Qbtech AB | 2004 | — |
| −1 | K122149 | QBTES | Qbtech AB | 2012 | — |
| 0 (this device) | K133382 | QB Test | Qbtech AB | 2014 | — |
| +1 | K173915 | Test of Variables of Attention (T.O.V.A.) | The Tova Company | 2018 | — |
| +1 | K143468 | QbCheck | Qbtech AB | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K122149 | QBTESSummary page 1…Sweden Tel: +46 706339209 Fax: +46 8 790 09 78 Contact person: Hans Bostrom E-mail: [email protected] QbTest Recorder, attention task performance LQD QbTest (K122149) QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individu… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K173915 (The Tova Company, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122149.
How does its category compare?
All LQD devicesLQD Recorder, Attention Task Performance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LQD
1in 2018
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD (Attention-Deficit Hyperactivity Disorder) and in the evaluation of treatment interventions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133382 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133382: QB Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133382
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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