Cleared Special

K043080 - HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K043080 is an FDA 510(k) clearance for HEPARIN DOSE RESPONSE CONTROLS, manufactured by Medtronic Vascular. The device is a Class 2 Hematology device with product code JOX cleared through the Special 510(k) pathway after a 25-day FDA review.

K043080 · Medtronic Vascular · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
25d
Days
Class 2
Risk

K043080 is an FDA 510(k) clearance for the HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 3, 2004 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5680 - 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.

FDA 510(k) Submission Details - K043080

510(k) Number K043080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date December 03, 2004
Days to Decision 25 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
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

JOX Device Classification - Class 2, Special Controls

Product Code JOX Analyzer, Heparin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5680
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 - JOX Analyzer, Heparin, Automated

All 14
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K043080.
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · Medtronic, Inc. · Nov 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · Medtronic, Inc. · Oct 2010
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K051040 · Medtronic Perfusion Systems · May 2005
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070 · Medtronic Vascular · Oct 2004
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
K993519 · Cardiovascular Diagnostics, Inc. · Jan 2000
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
K922031 · Medtronic Hemotec, Inc. · Jul 1992
K043080 · HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Download PDF FDA Summary Medtronic Vascular