510(k) · Cleared
ClearedGordon Diagnostic System Model I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Diagnostics, Inc. · LQD Recorder, Attention Task Performance
Cleared on Jun 2, 1986 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jun 2, 1986
- Review
- 175 days
- Class
- Class U
- Product code
- LQD
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK854903 Gordon Diagnostic System Model IClinical Diagnostics, Inc. · 1986
- Descendant · cites it directly · 6 of its ownK020800 Optax SystemOptax Systems, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK040894 QbtestQbtech AB · 2004
- Descendant · 3 generations on · 4 of its ownK122149 QBTESQbtech AB · 2012
- Descendant · 4 generations on · 2 of its ownK133382 QB TestQbtech AB · 2014
- Descendant · 5 generations on · 0 of its ownK173915 Test of Variables of Attention (T.O.V.A.)The Tova Company · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K020800Optax SystemOptax Systems, Inc. · 2002 · cites it directly6descendants
- K040894QbtestQbtech AB · 2004 · 2 generations on5descendants
- K122149QBTESQbtech AB · 2012 · 3 generations on4descendants
- K133382QB TestQbtech AB · 2014 · 4 generations on2descendants
- K173915Test of Variables of Attention (T.O.V.A.)The Tova Company · 2018 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854903 | Gordon Diagnostic System Model I | Clinical Diagnostics, Inc. | 1986 | — |
| +1 | K020800 | Optax System | Optax Systems, Inc. | 2002 | — |
| +2 | K040894 | Qbtest | Qbtech AB | 2004 | — |
| +3 | K122149 | QBTES | Qbtech AB | 2012 | — |
| +4 | K133382 | QB Test | Qbtech AB | 2014 | — |
| +5 | K173915 | Test of Variables of Attention (T.O.V.A.) | The Tova Company | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K020800 (Optax Systems, Inc., 2002) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K854903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K854903: Gordon Diagnostic System Model I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854903
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026