510(k) Report

FDA applicant

Bio Medicus, Inc.

Eden Prairie, MN15 decisions1983–19922 recalls

FDA records 15 decisions for Bio Medicus, Inc. (Eden Prairie, MN) from 1983 to 1992: 15 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and DWA (Control, Pump Speed, Cardiopulmonary Bypass). 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 Bio Medicus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2018

2008: 12018: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 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?

  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type3decisions
  • DWAControl, Pump Speed, Cardiopulmonary Bypass3decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DQYCatheter, Percutaneous1decision
  • LIODevice, Specimen Collection1decision
  • DTZOxygenator, Cardiopulmonary Bypass1decision

Also: DPT (1), DYB (1), DWJ (1), DTL (1).

Who builds on its devices?

Later devices cite its devices 19 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.

  • K852698Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 19854cite it
  • K884129Bio-Medicus Percutaneous Cannula & Introducer SetBio Medicus, Inc. · 19883cite it
  • K852807Bio Medicus Bio Pump Model BP-50Bio Medicus, Inc. · 19853cite it
  • K872033Bio-Medicus Cannula-TubingBio Medicus, Inc. · 19873cite it
  • K830858Bio-Probe System-Blood Flow ProbeBio Medicus, Inc. · 19832cite it
  • K901253(PBS) Portable Bypass System, Model 1000Bio Medicus, Inc. · 19901cites it

What has FDA decided for it lately?

  • K920761Urine Cultur Stabilization Transport TubeBio Medicus, Inc. · 1992
  • K903410Bio-Medicus Cannula IntroducerBio Medicus, Inc. · 1990
  • K901253(PBS) Portable Bypass System, Model 1000Bio Medicus, Inc. · 1990
  • K901584Bio-Medicus Bio Console Models 540 a B CBio Medicus, Inc. · 1990
  • K894980Bio-Cal 370 Heater/CoolerBio Medicus, Inc. · 19891 recall
  • K884129Bio-Medicus Percutaneous Cannula & Introducer SetBio Medicus, Inc. · 19881 recall
  • K883956Bio-Medicus Tubing ConnectorsBio Medicus, Inc. · 1988
  • K872033Bio-Medicus Cannula-TubingBio Medicus, Inc. · 1987

All 15 as Bio Medicus, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K894980BIO CAL (R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL…Feb 8, 2018Class II
  • K884129Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015May 9, 2008