510(k) Report

FDA applicant

Medtronic Bio-Medicus, Inc.

Eden Prairie, MN13 decisions1992–19982 recalls

FDA records 13 decisions for Medtronic Bio-Medicus, Inc. (Eden Prairie, MN) from 1992 to 1998: 13 510(k) clearances. Most are in product codes DWA (Control, Pump Speed, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 7 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medtronic Bio-Medicus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Bio-Medicus, Inc. since 2007.

Recalls per year

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Bio-Medicus, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWAControl, Pump Speed, Cardiopulmonary Bypass6decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type1decision
  • DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1decision
  • DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass1decision
  • DPTProbe, Blood-Flow, Extravascular1decision

Also: DWB (1).

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 199810cite it
  • K924642Medtronic Bio-Medicus Femoral Cannula/IntroducerMedtronic Bio-Medicus, Inc. · 199310cite it
  • K936091Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerMedtronic Bio-Medicus, Inc. · 19943cite it
  • K924643Medtronic Bio-Medicus Cannula Insertion KitMedtronic Bio-Medicus, Inc. · 19922cite it
  • K954501Biotrend Oxygen Saturation & Hematocrit SystemMedtronic Bio-Medicus, Inc. · 19961cites it
  • K924205Medtronic Bio-Medicus Bio-Console Model 550Medtronic Bio-Medicus, Inc. · 19931cites it

What has FDA decided for it lately?

  • K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998
  • K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
  • K954501Biotrend Oxygen Saturation & Hematocrit SystemMedtronic Bio-Medicus, Inc. · 1996
  • K941922Medsat Oxygen Saturation SystemMedtronic Bio-Medicus, Inc. · 1995
  • K936091Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerMedtronic Bio-Medicus, Inc. · 1994
  • K941921Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550Medtronic Bio-Medicus, Inc. · 19941 recall
  • K924208Bio-Probe (R) Blood Flow Monitoring Syst (TX-50/50P)Medtronic Bio-Medicus, Inc. · 1993
  • K926357Medtronic Bio-Medicus Handcrank Model 150Medtronic Bio-Medicus, Inc. · 1993

All 13 as Medtronic Bio-Medicus, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K051303Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord…Apr 21, 2010
  • K924642Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog…May 9, 2008