Cleared Traditional

K923594 - CLOTTRAC COAGULATION CONTROL

K923594 is an FDA 510(k) clearance for CLOTTRAC COAGULATION CONTROL, manufactured by Medtronic Hemotec, Inc.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K923594 · Medtronic Hemotec, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
63d
Days
Class 2
Risk

K923594 is an FDA 510(k) clearance for the CLOTTRAC COAGULATION CONTROL. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Medtronic Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 63 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.

View all Medtronic Hemotec, Inc. devices

FDA 510(k) Submission Details - K923594

510(k) Number K923594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date September 21, 1992
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
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 15
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K923594.
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
K964609 · Array Medical, Inc. · Mar 1997
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · International Technidyne Corp. · Aug 1996
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994
HEMOCHRON(R) KACT
K913861 · International Technidyne Corp. · Oct 1991
HEMOCHRON THROMBOCHRONOMETER
K832189 · International Technidyne Corp. · Oct 1983
ACTIVATOR
K790346 · Tri-Med, Inc. · Mar 1979