Cleared Traditional

K902081 - CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL

K902081 is an FDA 510(k) clearance for CLOTTRAC(TM) IBEX HEPARINASE HR ACT CAR..., manufactured by Hemotec, Inc.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K902081 · Hemotec, Inc. · Hematology device
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Jul 1990
Decision
56d
Days
Class 2
Risk

K902081 is an FDA 510(k) clearance for the CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K902081

510(k) Number K902081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date July 03, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBP Device Classification - Class 2, Special Controls

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 - JBP Activated Whole Blood Clotting Time

All 23
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K902081.
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994
CLOTTRAC COAGULATION CONTROL
K923594 · Medtronic Hemotec, Inc. · Sep 1992
HEMOCHRON(R) KACT
K913861 · International Technidyne Corp. · Oct 1991
TE-25 COAGURO METER
K854686 · Future Impex Corp. · Jun 1986
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
K860122 · Medical Device Consultants, Inc. · Apr 1986
HEMOTEC ACT I SYSTEM
K843459 · Hemotec, Inc. · Dec 1984
K902081 · CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
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