Cleared Traditional

K070286 - BIO-CONSOLE

K070286 is the FDA 510(k) clearance for BIO-CONSOLE by Medtronic. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

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 11
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K070286.
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
K200306 · Abbott (Formerly Thoratec Corporation) · Mar 2020
CentriMag Acute Circulatory Support System
K191557 · Thoratec Corporation (Now Part of Abbott) · Jul 2019
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · Medtronic, Inc. · Jul 2013
BARD ISOFLOW BLOOD PUMP
K971421 · C.R. Bard, Inc. · May 1998
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739 · 3M Health Care, Sarns · Nov 1995
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · Gambro, Inc. · Aug 1984