Cleared Traditional

K150041 - CORA (Coagulation Resonance Analysis) System

K150041 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 JPA cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K150041 · Coramed Technologies, LLC · Hematology device
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Jun 2015
Decision
168d
Days
Class 2
Risk

K150041 is an FDA 510(k) clearance for the CORA (Coagulation Resonance Analysis) System. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Coramed Technologies, LLC (Niles, US). The FDA issued a Cleared decision on June 26, 2015 after a review of 168 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 Coramed Technologies, LLC devices

FDA 510(k) Submission Details - K150041

510(k) Number K150041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date June 26, 2015
Days to Decision 168 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
55d slower than avg
Panel avg: 113d · This submission: 168d
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 K150041.
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K151259 · Siemens Healthcare Diagnostics Products GmbH · Jan 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · Siemens Healthcare Diagnostic Products GmbH · Jan 2016
STA R MAX
K151867 · Diagnostica Stago S.A.S · Aug 2015
STA COMPACT MAX
K130090 · Diagnostica Stago, Incorporated · Feb 2013
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K093167 · Diagnostica Stago, Inc. · Dec 2009
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
K083518 · Instrumentation Laboratory CO · Mar 2009