# QFR: Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

- Device class: 2; regulation: 21 CFR 864.5430; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 57 days (middle half 30–104)
- 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)
- 2019: 1
- 2020: 1
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K213917: QStat Cartridge (2022), cited by 2
- DEN180017: Quantra Hemostasis Analyzer, QPlus Cartridge (2019), cited by 2
- K240045: QStat Cartridge (2024), cited by 1
- K230461: Quantra Hemostasis Analyzer (2023), cited by 1
- K223433: Quantra QPlus System (2022), cited by 1

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