# K241737: Sway System Sports Plus

- Pathway: 510(k) (Traditional)
- Applicant: Sway Medical, Inc.
- Decided: Feb 15, 2025 after 243 days
- Product code: POM (Computerized Cognitive Assessment Aid For Concussion)
- Device class: 2
- Regulation: 21 CFR 882.1471
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150037 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170551: ImPACT Quick Test, Impact Applications, Inc. (2017) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K241737
Methodology: https://510kreport.com/methodology