Cleared Special

K223433 - Quantra QPlus System (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223433 · Hemosonics, LLC · Hematology device
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Dec 2022
Decision
29d
Days
Class 2
Risk

K223433 is an FDA 510(k) clearance for the Quantra QPlus System. Classified as Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (product code QFR), Class II - Special Controls.

Submitted by Hemosonics, LLC (Durham, US). The FDA issued a Cleared decision on December 13, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5430 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemosonics, LLC devices

Submission Details

510(k) Number K223433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date December 13, 2022
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

All 7
Devices cleared under the same product code (QFR) and FDA review panel - the closest regulatory comparables to K223433.
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