De Novo · Granted
GrantedCognivue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerebral Assessment Systems, Inc. · PKQ Computerized Cognitive Assessment Aid
Granted on Jun 5, 2015 as a new device type through De Novo after a 723-day review. 8 later devices descend from it.
- Decided
- Jun 5, 2015
- Review
- 723 days
- Class
- Class II
- Product code
- PKQ
- Recalls
- None
8 later devices descend from it, 1 citing it directly.
- This deviceDEN130033 CognivueCerebral Assessment Systems, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK150154 ANAM Test System: Military BatteryVista Lifesciences, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK161068 Ahead 300Brainscope Company, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK181179 BrainScope OneBrainscope Company, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK183241 BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK190815 BrainScope TBIBrainscope Company, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150154ANAM Test System: Military BatteryVista Lifesciences, Inc. · 2015 · cites it directly7descendants
- K161068Ahead 300Brainscope Company, Inc. · 2016 · 2 generations on6descendants
- K181179BrainScope OneBrainscope Company, Inc. · 2018 · 3 generations on5descendants
- K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019 · 2 generations on3descendants
- K190815BrainScope TBIBrainscope Company, Inc. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130033 | Cognivue | Cerebral Assessment Systems, Inc. | 2015 | — |
| +1 | K150154 | ANAM Test System: Military Battery | Vista Lifesciences, Inc. | 2015 | — |
| +2 | K161068 | Ahead 300 | Brainscope Company, Inc. | 2016 | — |
| +3 | K181179 | BrainScope One | Brainscope Company, Inc. | 2018 | — |
| +2 | K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019 | — |
| +3 | K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 PKQ? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150154 | ANAM Test System: Military Battery | 2015 | 7 |
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, K150154 (Vista Lifesciences, Inc., 2015) has gone furthest, with 7 descendants of its own.
How does its category compare?
All PKQ devicesPKQ Computerized Cognitive Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PKQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PKQ
Too few PKQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PKQ
No recall names PKQ since 2007.
Adverse event reports per year · PKQ
1in 2025
MAUDE reports naming product code PKQ, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 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 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
indicated for use as an adjunctive tool for evaluating perceptual and memory function in individuals aged 55-95 years old
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130033 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130033: Cognivue.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130033
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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