De Novo · Granted
GrantedImPACT Computerized Neurocognitive Concussion Management Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impact Applications, Inc. · POM Computerized Cognitive Assessment Aid For Concussion
Granted on Aug 22, 2016 as a new device type through De Novo after a 377-day review. 7 later devices descend from it.
- Decided
- Aug 22, 2016
- Review
- 377 days
- Class
- Class II
- Product code
- POM
- Recalls
- None
7 later devices descend from it, 3 citing it directly.
- This deviceDEN150037 ImPACT Computerized Neurocognitive Concussion Management AidImpact Applications, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK170209 ImPACTImpact Applications, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK181223 ImPACTImpact Applications, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK202485 ImPACT Version 4Impact Applications, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK170551 ImPACT Quick TestImpact Applications, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK241737 Sway System Sports PlusSway Medical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170209ImPACTImpact Applications, Inc. · 2017 · cites it directly3descendants
- K181223ImPACTImpact Applications, Inc. · 2018 · 2 generations on2descendants
- K202485ImPACT Version 4Impact Applications, Inc. · 2020 · 3 generations on1descendant
- K170551ImPACT Quick TestImpact Applications, Inc. · 2017 · cites it directly1descendant
- K241737Sway System Sports PlusSway Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Impact Applications, Inc. | 2016 | — |
| +1 | K170209 | ImPACT | Impact Applications, Inc. | 2017 | — |
| +2 | K181223 | ImPACT | Impact Applications, Inc. | 2018 | — |
| +3 | K202485 | ImPACT Version 4 | Impact Applications, Inc. | 2020 | — |
| +1 | K170551 | ImPACT Quick Test | Impact Applications, Inc. | 2017 | — |
| +2 | K241737 | Sway System Sports Plus | Sway Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
3 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, K170209 (Impact Applications, Inc., 2017) has gone furthest, with 3 descendants of its own.
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. 2016, 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?
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59. ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment…
Read the full statement (102 words)
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.
ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.
ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.
ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150037 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150037: ImPACT Computerized Neurocognitive Concussion Management Aid.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150037
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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