# Sorin Biomedica, Fiat, USA, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 20 (1980–1994): 20 510(k) clearances
- Product codes: DXY (2), CDZ (2), KRL (2), DTZ (2), DTW (1), CHP (1), DTB (1), CIB (1), CEW (1), DTR (1), CGR (1), LCS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Dideco S.P.A.: 1 (https://510kreport.com/company/dideco)
- Zenyx Scientific, Ltd.: 1 (https://510kreport.com/company/zenyx-scientific)
- Medtronic Cardiac Surgery, Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic-cardiac-surgery-medtronic)
- Lifestream Int'L, Inc.: 1 (https://510kreport.com/company/lifestream-int-l)
- Gish Biomedical, Inc.: 1 (https://510kreport.com/company/gish-biomedical)
- Minntech Corp.: 1 (https://510kreport.com/company/minntech)
- Sorin Biomedical, Inc.: 1 (https://510kreport.com/company/sorin-biomedical)

## Its most-cited devices
- K922933: Sorin Monolyrh Integrated Membrane Lung (1992), cited by 3
- K925369: BCD Advanced Blood Carioplegia Systems (1993), cited by 3
- K800775: Aldoctk-125 (1980), cited by 1

## Recent decisions
- K931444: Plexus 2 & 3.5 Hollow Fiber Oxygenators (May 27, 1994)
- K925661: Stockert CAPS1 Cardioplegic Control Module (May 18, 1993)
- K925369: BCD Advanced Blood Carioplegia Systems (Mar 26, 1993)
- K925615: Shiley Specialized,Pediatric & Neonatal Trach.Tube (Mar 26, 1993)
- K924354: Stockert Caps Low Level Detect II/Bubble Monitor (Feb 18, 1993)
- K925541: Stockert 1/4 Bubble Sensor (Feb 2, 1993)
- K922933: Sorin Monolyrh Integrated Membrane Lung (Nov 30, 1992)
- K854963: S80 Implantable Cardiac Pacing Lead (Jun 24, 1986)

Source page: https://510kreport.com/company/sorin-biomedica-fiat-usa