Cleared Traditional

K952514 - COACUTE HEPARIN

K952514 is an FDA 510(k) clearance for COACUTE HEPARIN, manufactured by Chromogenix AB. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K952514 · Chromogenix AB · Hematology device
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Nov 1995
Decision
173d
Days
Class 2
Risk

K952514 is an FDA 510(k) clearance for the COACUTE HEPARIN. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Chromogenix AB (Franklin, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 173 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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 Chromogenix AB devices

FDA 510(k) Submission Details - K952514

510(k) Number K952514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date November 20, 1995
Days to Decision 173 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 113d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFF Device Classification - Class 2, Special Controls

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 33
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K952514.
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · Medical Diagnostic Technologies, Inc. · Aug 1997
MDA HEPARIN ANTI-X ASSAY
K965076 · Organon Teknika Corp. · Mar 1997
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
THE HEPANORM HBPM/LMWH KIT
K943514 · American Bioproducts Co. · Sep 1995
HBPM/LMWH CONTROL KIT
K943519 · American Bioproducts Co. · Sep 1995
HEPARIN CONTROL KIT
K943520 · American Bioproducts Co. · Sep 1995