Cleared Traditional

K875089 - HEPCON SYSTEM B-10 ACTIVATED CLOT TIME ...

K875089 is the FDA 510(k) clearance for HEPCON SYSTEM B-10 ACTIVATED CLOT TIME ... by Hemotec, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K875089 · Hemotec, Inc. · Hematology device
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Mar 1988
Decision
91d
Days
Class 2
Risk

K875089 is an FDA 510(k) clearance for the HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 91 days - within the typical 510(k) review window.

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 Hemotec, Inc. devices

Submission Details

510(k) Number K875089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date March 09, 1988
Days to Decision 91 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 113d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 119
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K875089.
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · King Diagnostics, Inc. · Oct 1988
OWREN'S VERONAL BUFFER
K883484 · Helena Laboratories · Aug 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · Instrumentation Laboratory CO · Jun 1988
CHROM-TROL
K872377 · Helena Laboratories · Jul 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · International Technidyne Corp. · Jun 1987
COAG-A-MATE(R) XC
K870960 · Organon Teknika Corp. · Mar 1987