# K231688: ImPACT Version 4

- Pathway: 510(k) (Traditional)
- Applicant: Impact Applications, Inc.
- Decided: Sep 16, 2023 after 99 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: 4 generations back to DEN150037 (2016). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202485: ImPACT Version 4, Impact Applications, Inc. (2020) Summary page 4.

## Indications for use
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 12-80.

Source page: https://510kreport.com/device/K231688
Methodology: https://510kreport.com/methodology