510(k) · Cleared
ClearedANAM Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Lifesciences, Inc. · POM Computerized Cognitive Assessment Aid For Concussion
Cleared on Mar 25, 2021 as substantially equivalent to DEN150037 (Impact Applications, Inc., 2016) after a 303-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Mar 25, 2021
- Review
- 303 days
- Class
- Class II
- Product code
- POM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150037 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backDEN150037 ImPACT Computerized Neurocognitive Concussion Management AidImpact Applications, Inc. · 2016
- This deviceK201376 ANAM Test SystemVista Lifesciences, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Impact Applications, Inc. | 2016 | — |
| 0 (this device) | K201376 | ANAM Test System | Vista Lifesciences, Inc. | 2021 | — |
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 POM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new POM device
- #1 K241737 Sway System Sports Plusscore 9.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | DEN150037 | ImPACT Computerized Neurocognitive Concussion Management AidSummary page 4…Concussion Panel: Neurology Product Code: POM Predicate Device: DEN150037, ImPACT Page 1 510(k) Premarke… | 2016 |
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.
- 2 other devices also cite its predicate DEN150037.
How does its category compare?
All POM devicesPOM Computerized Cognitive Assessment Aid For Concussion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · POM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POM
Too few POM 510(k)s in any year since 2007 to give a median.
Recalls per year · POM
No recall names POM since 2007.
Adverse event reports per year · POM
No MAUDE report names POM 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.
The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201376: ANAM Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201376
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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