# PIW: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

- Device class: 2; regulation: 21 CFR 882.1450; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 162 days (middle half 153–172)
- 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)
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 2
- 2019: 2
- 2023: 1
- 2025: 1

## Most-cited predicates
- K181179: BrainScope One (2018), cited by 2
- K143643: Brainscope Ahead 200 (2015), cited by 1
- K161068: Ahead 300 (2016), cited by 1
- DEN140025: BrainScope Ahead 100 (2014), cited by 1
- K183241: BrainScope TBI (Model: Ahead 400) (2019), cited by 1
- K231914: Nurochek-II System (2023), cited by 1
- K190815: BrainScope TBI (2019), cited by 1

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