Cleared Special

K103314 - CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

K103314 is an FDA 510(k) clearance for CLOTRAC HEPARINASE TEST CARTIDGE (HTC) ..., manufactured by Medtronic, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Special 510(k) pathway after a 23-day FDA review.

K103314 · Medtronic, Inc. · Hematology device
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Dec 2010
Decision
23d
Days
Class 2
Risk

K103314 is an FDA 510(k) clearance for the CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K103314

510(k) Number K103314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2010
Decision Date December 03, 2010
Days to Decision 23 days
Submission Type Special
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
90d faster than avg
Panel avg: 113d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
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 - GGN Plasma, Coagulation Control

All 82
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