Cleared Traditional

K213917 - QStat Cartridge (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213917 · Hemosonics, LLC · Hematology device
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Nov 2022
Decision
349d
Days
Class 2
Risk

K213917 is an FDA 510(k) clearance for the QStat Cartridge. Classified as Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (product code QFR), Class II - Special Controls.

Submitted by Hemosonics, LLC (Charlottesville, US). The FDA issued a Cleared decision on November 29, 2022 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5430 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hemosonics, LLC devices

Submission Details

510(k) Number K213917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2021
Decision Date November 29, 2022
Days to Decision 349 days
Submission Type Traditional
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
236d slower than avg
Panel avg: 113d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K213917.
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