510(k) · Cleared
ClearedANAM Test System: Military Battery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Lifesciences, Inc. · PKQ Computerized Cognitive Assessment Aid
Cleared on Aug 28, 2015 as substantially equivalent to DEN130033 (Cerebral Assessment Systems, Inc., 2015) after a 217-day review. Its family tree reaches back 1 generation to 2015. 7 later devices descend from it.
- Decided
- Aug 28, 2015
- Review
- 217 days
- Class
- Class II
- Product code
- PKQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130033 (2015). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130033 CognivueCerebral Assessment Systems, Inc. · 2015
- This deviceK150154 ANAM Test System: Military BatteryVista Lifesciences, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK161068 Ahead 300Brainscope Company, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK181179 BrainScope OneBrainscope Company, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK183241 BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK190815 BrainScope TBIBrainscope Company, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK231914 Nurochek-II SystemHeadsafe Mfg Pty, Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161068Ahead 300Brainscope Company, Inc. · 2016 · cites it directly6descendants
- K181179BrainScope OneBrainscope Company, Inc. · 2018 · 2 generations on5descendants
- K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019 · cites it directly3descendants
- K190815BrainScope TBIBrainscope Company, Inc. · 2019 · 2 generations on2descendants
- K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130033 | Cognivue | Cerebral Assessment Systems, Inc. | 2015 | — |
| 0 (this device) | K150154 | ANAM Test System: Military Battery | Vista Lifesciences, Inc. | 2015 | — |
| +1 | K161068 | Ahead 300 | Brainscope Company, Inc. | 2016 | — |
| +2 | K181179 | BrainScope One | Brainscope Company, Inc. | 2018 | — |
| +1 | K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019 | — |
| +2 | K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019 | — |
| +3 | K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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
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 |
|---|---|---|---|
| * | DEN130033 | CognivueSummary page 4…lassification Regulation: 882.1470 Panel: Neurology Product Code: PKQ Predicate Device: DEN130033, Cerebral Assessment Systems Cognivue Indication for Use: The ANAM Test System: Military Battery provides clinicians with objec… | 2015 |
What descends from it? (7)
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?
- Its one ancestor has no recall.
- Of its descendants, K161068 (Brainscope Company, Inc., 2016) has gone furthest, with 6 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?
The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150154: ANAM Test System: Military Battery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150154
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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