QFR

Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

Product code
QFR
Device name
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device class
Class 2
21 CFR
21 CFR 864.5430
Medical specialty
Hematology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
8 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-08-25.

NumberDecision dateApplicantDevice nameSummary
K2514042025-08-25Hemosonics, LLCQuantra QStat CartridgeFDA
K2400452024-03-27Hemosonics, LLCQStat CartridgePDF

1 summaries are archived here for direct download.

Official FDA classification page: QFR
Classification and pathway per current FDA publications. Data from openFDA (CC0).