Cleared Traditional

K140893 - CORA (COAGULATION RESONANCE ANALYSIS) S...

K140893 is the FDA 510(k) clearance for CORA (COAGULATION RESONANCE ANALYSIS) S... by Coramed Technologies, LLC. It is a Class 2 Hematology device (product code JOZ) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K140893 · Coramed Technologies, LLC · Hematology device
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Jan 2015
Decision
270d
Days
Class 2
Risk

K140893 is an FDA 510(k) clearance for the CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Coramed Technologies, LLC (Niles, US). The FDA issued a Cleared decision on January 3, 2015 after a review of 270 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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 Coramed Technologies, LLC devices

Submission Details

510(k) Number K140893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2014
Decision Date January 03, 2015
Days to Decision 270 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 113d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 - JOZ System, Automated Platelet Aggregation

All 13
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K140893.
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K023761 · Helena Laboratories · Feb 2003
PLATELETWORKS
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K002885 · Dade Behring, Inc. · Jun 2001