Cleared Traditional

K232018 - Citrated: K

K232018 is an FDA 510(k) clearance for Citrated: K, manufactured by Haemonetics Corporation. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K232018 · Haemonetics Corporation · Hematology device
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Mar 2024
Decision
266d
Days
Class 2
Risk

K232018 is an FDA 510(k) clearance for the Citrated: K, KH, RTH, FFH. 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 March 29, 2024 after a review of 266 days - an extended review cycle.

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

FDA 510(k) Submission Details - K232018

510(k) Number K232018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date March 29, 2024
Days to Decision 266 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
153d slower than avg
Panel avg: 113d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K232018.
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TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
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ACL TOP 970 CL
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K221359 · Instrumentation Laboratory CO · Sep 2023
STA R Max 3, STA Compact Max 3
K212183 · Diagnostica Stago S.A.S · Jun 2023