Cleared Traditional

K952514 - COACUTE HEPARIN

K952514 is the FDA 510(k) clearance for COACUTE HEPARIN by Chromogenix AB. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 29
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