FDA product code QFR: Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
QFR is the FDA product code for coagulation system for the measurement of whole blood viscoelastic properties. It is a Class II device, regulated under 21 CFR 864.5430 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under QFR, 6 in the last five years. The average 510(k) review took 101 days (median 74); 96 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties |
| Device class | Class II |
| Regulation | 21 CFR 864.5430 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for QFR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 74 |
| 2022 | 2 | 189 |
| 2023 | 2 | 30 |
| 2024 | 1 | 82 |
| 2025 | 1 | 111 |
Compare with all 510(k) review times · Search every QFR clearance
Top QFR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hemosonics, LLC | 7 | 2025-08-25 |
Most recent QFR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251404 | Hemosonics, LLC | Quantra QStat Cartridge | 2025-08-25 | 111 |
| K240045 | Hemosonics, LLC | QStat Cartridge | 2024-03-27 | 82 |
| K232215 | Hemosonics, LLC | Quantra Hemostasis Analyzer | 2023-08-24 | 29 |
| K230461 | Hemosonics, LLC | Quantra Hemostasis Analyzer | 2023-03-24 | 31 |
| K223433 | Hemosonics, LLC | Quantra QPlus System | 2022-12-13 | 29 |
Recalls for QFR devices
openFDA lists no recalls for product code QFR.
Frequently asked questions
What is FDA product code QFR?
QFR is the FDA product code for coagulation system for the measurement of whole blood viscoelastic properties. It is a Class II device, regulated under 21 CFR 864.5430 and reviewed by the Hematology panel.
What device class is QFR?
Class II, regulation 21 CFR 864.5430. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFR?
Across 7 cleared submissions the average was 101 days from receipt to decision (median 74).
Which companies have the most QFR clearances?
Hemosonics, LLC (7).
Next steps
- Run an FDA pathway report with predicate devices for product code QFR
- Run a recall and safety report across every QFR manufacturer
- Watch product code QFR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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