# DEN150037: ImPACT Computerized Neurocognitive Concussion Management Aid

- Pathway: De Novo (Direct)
- Applicant: Impact Applications, Inc.
- Decided: Aug 22, 2016 after 377 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K170209: ImPACT (2017), 3 descendants of its own
- K181223: ImPACT (2018), 2 descendants of its own
- K202485: ImPACT Version 4 (2020), 1 descendant of its own
- K170551: ImPACT Quick Test (2017), 1 descendant of its own
- K241737: Sway System Sports Plus (2025), 0 descendants of its own

## 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 12-59. 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.

Source page: https://510kreport.com/device/DEN150037
Methodology: https://510kreport.com/methodology