510(k) · Cleared
ClearedOptax System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optax Systems, Inc. · LQD Recorder, Attention Task Performance
Cleared on Jun 10, 2002 as substantially equivalent to K854903 (Clinical Diagnostics, Inc., 1986) after a 90-day review. Its family tree reaches back 1 generation to 1986. 6 later devices descend from it.
- Decided
- Jun 10, 2002
- Review
- 90 days
- Class
- Class U
- Product code
- LQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854903 (1986). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK854903 Gordon Diagnostic System Model IClinical Diagnostics, Inc. · 1986
- This deviceK020800 Optax SystemOptax Systems, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK040894 QbtestQbtech AB · 2004
- Descendant · 2 generations on · 4 of its ownK122149 QBTESQbtech AB · 2012
- Descendant · 3 generations on · 2 of its ownK133382 QB TestQbtech AB · 2014
- Descendant · 4 generations on · 0 of its ownK173915 Test of Variables of Attention (T.O.V.A.)The Tova Company · 2018
- Descendant · 4 generations on · 0 of its ownK143468 QbCheckQbtech AB · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040894QbtestQbtech AB · 2004 · cites it directly5descendants
- K122149QBTESQbtech AB · 2012 · 2 generations on4descendants
- K133382QB TestQbtech AB · 2014 · 3 generations on2descendants
- K173915Test of Variables of Attention (T.O.V.A.)The Tova Company · 2018 · 4 generations on0descendants
- K143468QbCheckQbtech AB · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854903 | Gordon Diagnostic System Model I | Clinical Diagnostics, Inc. | 1986 | — |
| 0 (this device) | K020800 | Optax System | Optax Systems, Inc. | 2002 | — |
| +1 | K040894 | Qbtest | Qbtech AB | 2004 | — |
| +2 | K122149 | QBTES | Qbtech AB | 2012 | — |
| +3 | K133382 | QB Test | Qbtech AB | 2014 | — |
| +4 | K173915 | Test of Variables of Attention (T.O.V.A.) | The Tova Company | 2018 | — |
| +4 | K143468 | QbCheck | Qbtech AB | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K854903 | Gordon Diagnostic System Model ISummary page 1…JsualName: RECORDER, ATTENTION TASK PERFORMANCE 3. Identification of Predicate or Legally Marketed Device Gordon Diagnostic System cleared under K854903. 4. Device Description OPTAX (Optical Tracking and Attention test) is a 15 minutenon-invasive, ofice-based test that was… | 1986 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040894 | Qbtest | 2004 | 5 |
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?
How does its category compare?
All LQD devicesLQD Recorder, Attention Task Performance: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OpTAx results should be interpreted only by qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020800: Optax System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020800
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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