# Medtronic Bio-Medicus, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 13 (1992–1998): 13 510(k) clearances
- Product codes: DWA (6), DWF (2), KFM (1), DRY (1), DTY (1), DPT (1), DWB (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 29 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio Medicus, Inc.: 1 (https://510kreport.com/company/bio-medicus)
- Medtronic Blood Systems, Inc.: 1 (https://510kreport.com/company/medtronic-blood-systems)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Sorin Biomedical, Inc.: 1 (https://510kreport.com/company/sorin-biomedical)
- Quest Medical, Inc.: 1 (https://510kreport.com/company/quest-medical)
- 3M Health Care, Sarns: 1 (https://510kreport.com/company/3m-health-care-sarns)
- Medtronic Cardiac Surgery, Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic-cardiac-surgery-medtronic)

## Firms that cite its devices most
- Medtronic, Inc.: 8 (https://510kreport.com/company/medtronic)
- Cardiacassist, Inc.: 5 (https://510kreport.com/company/cardiacassist)
- Medtronic Perfusion Systems: 4 (https://510kreport.com/company/medtronic-perfusion-systems)
- Maquet Cardiopulmonary, AG: 2 (https://510kreport.com/company/maquet-cardiopulmonary)
- Levitronix, LLC: 2 (https://510kreport.com/company/levitronix)
- Abiomed, Inc.: 2 (https://510kreport.com/company/abiomed)
- A-Med Systems, Inc.: 2 (https://510kreport.com/company/a-med-systems)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)

## Its most-cited devices
- K973011: BPX80 Bio-Pump (BPX80) (1998), cited by 10
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer (1993), cited by 10
- K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller (1994), cited by 3
- K924643: Medtronic Bio-Medicus Cannula Insertion Kit (1992), cited by 2
- K954501: Biotrend Oxygen Saturation & Hematocrit System (1996), cited by 1
- K924205: Medtronic Bio-Medicus Bio-Console Model 550 (1993), cited by 1

## Recent decisions
- K973237: CSS-Cardioplegia Safety System (Apr 27, 1998)
- K973011: BPX80 Bio-Pump (BPX80) (Feb 25, 1998)
- K954501: Biotrend Oxygen Saturation & Hematocrit System (Jan 16, 1996)
- K941922: Medsat Oxygen Saturation System (Feb 17, 1995)
- K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller (Dec 23, 1994)
- K941921: Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550 (Jul 20, 1994)
- K924208: Bio-Probe (R) Blood Flow Monitoring Syst (TX-50/50P) (Jul 8, 1993)
- K926357: Medtronic Bio-Medicus Handcrank Model 150 (Jun 2, 1993)

Source page: https://510kreport.com/company/medtronic-bio-medicus