# K170551: ImPACT Quick Test

- Pathway: 510(k) (Traditional)
- Applicant: Impact Applications, Inc.
- Decided: Jun 21, 2017 after 117 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: 1 generation back to DEN150037 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150037: ImPACT Computerized Neurocognitive Concussion Management Aid, Impact Applications, Inc. (2016) Summary page 4.

## Most influential descendants
- K241737: Sway System Sports Plus (2025), 0 descendants of its own

## Indications for use
ImPACT Quick Test is intended for use as a computerized cognitive test aid in the assessment and management of concussion in individuals ages 12-70.

Source page: https://510kreport.com/device/K170551
Methodology: https://510kreport.com/methodology