# POM: Computerized Cognitive Assessment Aid For Concussion

- Device class: 2; regulation: 21 CFR 882.1471; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 243 days (middle half 171–273)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 2
- 2018: 1
- 2020: 1
- 2021: 1
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN150037: ImPACT Computerized Neurocognitive Concussion Management Aid (2016), cited by 3
- K170209: ImPACT (2017), cited by 1
- K181223: ImPACT (2018), cited by 1
- K170551: ImPACT Quick Test (2017), cited by 1
- K202485: ImPACT Version 4 (2020), cited by 1

Source page: https://510kreport.com/product-code/POM
Data by year (CSV): https://510kreport.com/product-code/POM.csv