Cleared Traditional

Quantra QStat Cartridge

K251404 · Hemosonics, LLC · Hematology
Aug 2025
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K251404 is an FDA 510(k) clearance for the Quantra QStat Cartridge, a Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (Class II — Special Controls, product code QFR), submitted by Hemosonics, LLC (Durham, US). The FDA issued a Cleared decision on August 25, 2025, 111 days after receiving the submission on May 6, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5430.

Submission Details

510(k) Number K251404 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2025
Decision Date August 25, 2025
Days to Decision 111 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code QFR — Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5430
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.