Cleared Traditional

K070286 - BIO-CONSOLE, MODEL 560

K070286 is an FDA 510(k) clearance for BIO-CONSOLE, manufactured by Medtronic. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K070286 · Medtronic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
113d
Days
Class 2
Risk

K070286 is an FDA 510(k) clearance for the BIO-CONSOLE, MODEL 560. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Medtronic (Minneapolis, US). The FDA issued a Cleared decision on May 22, 2007 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic devices

FDA 510(k) Submission Details - K070286

510(k) Number K070286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date May 22, 2007
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 K070286.
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 560
K080824 · Medtronic Perfusion Systems · May 2008
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
STOCKERT SCP RHYTHM
K042374 · Stockert Instrumente GmbH · Sep 2004