510(k) Report

510(k) · Cleared

Cleared

Test of Variables of Attention (T.O.V.A.) Version 9.0

K170082510(k) TraditionalCleared May 17, 2017127-day reviewClass U

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

The Tova Company · LQD Recorder, Attention Task Performance

Cleared on May 17, 2017 as substantially equivalent to K854903 (Clinical Diagnostics, Inc., 1986) after a 127-day review. Its family tree reaches back 1 generation to 1986.

Decided
May 17, 2017
Review
127 days
Class
Class U
Product code
LQD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K854903 (1986). No later device cites it as a predicate yet.

K854903 · Gordon Diagnostic System Model I · Clinical Diagnostics, Inc. · 19861985199019952000200520102015
  1. Root · 1 generation backK854903 Gordon Diagnostic System Model IClinical Diagnostics, Inc. · 1986
  2. This deviceK170082 Test of Variables of Attention (T.O.V.A.) Version 9.0The Tova Company · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K854903Gordon Diagnostic System Model IClinical Diagnostics, Inc.1986—
0 (this device)K170082Test of Variables of Attention (T.O.V.A.) Version 9.0The Tova Company2017—
FIG. 1 — Lineage of K170082, 1986–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K854903Gordon Diagnostic System Model I
Summary page 4
…me: Recorder, attention task performance Device class: Unclassified Predicate Device: The Gordon Diagnostic System Model I from Clinical Diagnostics Inc. (K854903) Device Description: The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous…
Clinical Diagnostics, Inc.1986—

Also cleared against K854903: 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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K854903.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · LQD

1in 2018

2012: 12014: 22016: 12017: 12018: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20121—00
20130—00
20142—00
20150—00
20161—00
20171—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K170082: Test of Variables of Attention (T.O.V.A.) Version 9.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170082

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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