Cleared Special

K243858 - TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (FDA 510(k) Clearance)

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

K243858 · Haemonetics Corporation · Hematology device
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Optimized for regulatory review, auditing and printing
Jan 2025
Decision
30d
Days
Class 2
Risk

K243858 is an FDA 510(k) clearance for the TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Haemonetics Corporation (Boston, US). The FDA issued a Cleared decision on January 15, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Haemonetics Corporation devices

Submission Details

510(k) Number K243858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date January 15, 2025
Days to Decision 30 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
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 180
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K243858.
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TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
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K232018 · Haemonetics Corporation · Mar 2024
ACL TOP 970 CL
K233790 · Instrumentation Laboratory · Dec 2023
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K221359 · Instrumentation Laboratory CO · Sep 2023