Cleared Traditional

K140893 - CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY

K140893 is an FDA 510(k) clearance for CORA (COAGULATION RESONANCE ANALYSIS) S..., manufactured by Coramed Technologies, LLC. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K140893

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
Combination Product No
PCCP Authorized No
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.

JOZ Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K140893.
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
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ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
K141427 · Accumetrics, Inc. · Jul 2015
AGGREGUIDE
K122162 · Aggredyne, Inc. · Dec 2013
MULTIPLATE 5.0 AGGREGOMETER
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DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · Dade Behring, Inc. · Jul 2006