# QLU: Anti-Factor Xa Activity Test System, Apixaban

- Device class: 2; regulation: 21 CFR 864.7295; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 253 days (middle half 252–253)
- Recalls: 1 (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)
- 2020: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- DEN190032: HemosIL Liquid Anti-Xa (2020), cited by 3
- K223187: HemosIL Liquid Anti-Xa (2023), cited by 1

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