Cleared Traditional

K080824 - BIO-CONSOLE 560

K080824 is an FDA 510(k) clearance for BIO-CONSOLE 560, manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K080824 · Medtronic Perfusion Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
44d
Days
Class 2
Risk

K080824 is an FDA 510(k) clearance for the BIO-CONSOLE 560. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on May 7, 2008 after a review of 44 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. 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 Perfusion Systems devices

FDA 510(k) Submission Details - K080824

510(k) Number K080824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2008
Decision Date May 07, 2008
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWA Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K080824.
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225 · Sorin Group Deutschland GmbH · Sep 2011
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468 · Sorin Group Deutschland GmbH · Jan 2011
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · Sorin Group Deutschland GmbH · Jul 2009
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
K061369 · Cardiacassist, Inc. · Aug 2006
BIO-CONSOLE, MODEL 560
K051303 · Medtronic Perfusion Systems · Jun 2005