510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240045Substantially Equivalent

QStat Cartridge

Hemosonics, LLC, Durham NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240045 is the FDA 510(k) clearance record for QStat Cartridge, a class II device, cleared for Hemosonics, LLC on under FDA product code QFR (Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties). FDA's definition for product code QFR reads: "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". FDA records list 8 510(k) clearances for Hemosonics, LLC, from to . As of , FDA records show no recalls naming K240045.

Clearance record

Decision date
Received
(82 days to decision)
Product code
QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Regulation
21 CFR 864.5430
Device class
Class II
Review panel
Hematology
Applicant
Hemosonics, LLC 4020 Stirrup Creek Dr., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFR

Trailing 12 months

FDA records hold no clearances under product code QFR in the trailing twelve months.

FDA records show no clearances under product code QFR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260