510(k) · Cleared
ClearedDANA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthrotronix, Inc. · LQD Recorder, Attention Task Performance
Cleared on Oct 15, 2014 as substantially equivalent to K122149 (Qbtech AB, 2012) after a 97-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Oct 15, 2014
- Review
- 97 days
- Class
- Class U
- Product code
- LQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854903 (1986). No later device cites it as a predicate yet.
- 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 deviceK141865 DANAAnthrotronix, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
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 4…ask Performance Recorder Classification Name: Recorder, Attention Task Performance Device Class: Unclassified Predicate Device: QbTest (K122149) Qbtech AB Unclassified Device Description: DANA is a mobile applicatio… | 2012 |
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 28 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- None of the 4 ancestors has a recall.
- 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?
DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, dementia, delirium, prescription and…
Read the full statement (94 words)
DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, dementia, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress).
DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141865: DANA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141865
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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