Cleared Special

K131964 - BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131964 · Medtronic, Inc. · Cardiovascular device
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Jul 2013
Decision
27d
Days
Class 2
Risk

K131964 is an FDA 510(k) clearance for the BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - the FDA cardiovascular device oversight 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

Submission Details

510(k) Number K131964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date July 24, 2013
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 36
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