Cleared Traditional Expedited

K954202 - PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

K954202 is an FDA 510(k) clearance for PLATELET FUNCTION TEST ASSAY CARTRIDGES..., manufactured by Medtronic Hemotec, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K954202 · Medtronic Hemotec, Inc. · Hematology device
Download Printable Device Report (PDF)
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Jun 1996
Decision
287d
Days
Class 2
Risk

K954202 is an FDA 510(k) clearance for the PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Medtronic Hemotec, Inc. (Parker, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 287 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 Medtronic Hemotec, Inc. devices

FDA 510(k) Submission Details - K954202

510(k) Number K954202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1995
Decision Date June 20, 1996
Days to Decision 287 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
174d slower than avg
Panel avg: 113d · This submission: 287d
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 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K954202.
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · Sysmex Corp. · Mar 1997
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · Helena Laboratories · Dec 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · Sigma Diagnostics, Inc. · Sep 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · Sigma Diagnostics, Inc. · Mar 1996
KC 1A COAGULATION ANALYZER/SET
K955724 · Sigma Diagnostics, Inc. · Mar 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
K955735 · Sigma Diagnostics, Inc. · Mar 1996