510(k) · Cleared
ClearedSway System Sports Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sway Medical, Inc. · POM Computerized Cognitive Assessment Aid For Concussion
Cleared on Feb 15, 2025 as substantially equivalent to K170551 (Impact Applications, Inc., 2017) after a 243-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Feb 15, 2025
- Review
- 243 days
- Class
- Class II
- Product code
- POM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150037 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K231688 ImPACT Version 4score 6.9 · 4 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.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
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. 2025, 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 Sway System Sports Plus is intended for use as a computerized cognitive assessment test to aid in the assessment and
management of concussion in individuals ages 18-24.
The Sway System Sports Plus is indicated for use when there is a suspected concussion or head injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241737: Sway System Sports Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241737
Report an extraction error
Are you the manufacturer?
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