QFR
8 FDA 510(k) clearances · Product code
82 daysmedian time to decision
349 days90th percentile
8clearances measured
FDA profile
- Official device name
- Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5430
- Medical specialty
- Hematology
- FDA definition
- A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Quantra QStat Cartridge (K251404) | Hemosonics, LLC | 2025-08-25 |
| QStat Cartridge (K240045) | Hemosonics, LLC | 2024-03-27 |
| Quantra Hemostasis Analyzer (K232215) | Hemosonics, LLC | 2023-08-24 |
| Quantra Hemostasis Analyzer (K230461) | Hemosonics, LLC | 2023-03-24 |
| Quantra QPlus System (K223433) | Hemosonics, LLC | 2022-12-13 |
| QStat Cartridge (K213917) | Hemosonics, LLC | 2022-11-29 |
| Quantra QPlus System (K201513) | Hemosonics, LLC | 2020-08-21 |
| Quantra Hemostasis Analyzer, QPlus Cartridge (DEN180017) | Hemosonics, LLC | 2019-03-12 |
Track QFR automatically
Every clearance here is in the API, with alerts when new ones post.