# QAT: Brain Trauma Assessment Test

- Device class: 2; regulation: 21 CFR 866.5830; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 90 days (middle half 89–90)
- 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)
- 2018: 1
- 2021: 1
- 2023: 2
- 2024: 2

## Most-cited predicates
- DEN170045: Banyan BTI (2018), cited by 3
- K201778: i-STAT TBI Plasma cartridge with the i-STAT Alinity System (2021), cited by 1
- K223602: Traumatic brain injury (TBI) test (2023), cited by 1

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