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Bio-Console 560 Extracorporeal Blood Pumping Console

by Medtronic, Inc.

510(k) K131964

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK131964 Date24 Jul 2013ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1313-2021 FDA Class I initiated 3 Mar 2021

    An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWA
Device Class
Class II
Regulation
21 CFR Part 870.4380
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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