FDA Product Code QFR: Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
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.
Leading manufacturers include Hemosonics, LLC.
FDA 510(k) Cleared Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Devices (Product Code QFR)
About Product Code QFR - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QFR since 2019, with 7 receiving FDA clearance (average review time: 131 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under QFR have taken an average of 111 days to reach a decision - down from 134 days historically, suggesting improved FDA processing for this classification.
QFR devices are reviewed by the Hematology panel. Browse all Hematology devices →