# Sorin Group Italia S.R.L.

- Location (FDA's records): Mirandola, IT
- FDA decisions: 63 (1995–2026): 63 510(k) clearances
- Product codes: DTZ (22), DWF (14), DTN (8), CAC (6), DTM (6), KDI (2), KRH (2), KFM (1), DTR (1), DRE (1)
- 510(k) review time since 2016: median 88 days, against 90 for FDA's reviews in the same codes and years (9 of 19 faster)
- Predicates its devices cite: 92 (40 its own); citations of its devices by later devices: 66 (40 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dideco S.P.A.: 24 (https://510kreport.com/company/dideco)
- Cobe Cardiovascular, Inc.: 8 (https://510kreport.com/company/cobe-cardiovascular)
- Sorin Biomedical, Inc.: 4 (https://510kreport.com/company/sorin-biomedical)
- Dlp, Inc.: 4 (https://510kreport.com/company/dlp)
- Shiley, Inc.: 3 (https://510kreport.com/company/shiley)
- Parexel International: 2 (https://510kreport.com/company/parexel-international)
- Cobe Renal Care, Inc.: 1 (https://510kreport.com/company/cobe-renal-care)
- Endoscopic Technologies, Inc.: 1 (https://510kreport.com/company/endoscopic-technologies)

## Firms that cite its devices most
- Eurosets S.R.L: 7 (https://510kreport.com/company/eurosets)
- Maquet Cardiopulmonary, AG: 4 (https://510kreport.com/company/maquet-cardiopulmonary)
- Qura S.R.L: 4 (https://510kreport.com/company/qura)
- Chalice Medical, Ltd.: 2 (https://510kreport.com/company/chalice-medical)
- Corcym S.r.l.: 2 (https://510kreport.com/company/corcym)
- Abiomed, Inc.: 1 (https://510kreport.com/company/abiomed)
- Parexel International: 1 (https://510kreport.com/company/parexel-international)
- Sorin Group Deutschland GmbH: 1 (https://510kreport.com/company/sorin-group-deutschland)

## Its most-cited devices
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior (2012), cited by 5
- K180448: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (2018), cited by 5
- K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir (2007), cited by 5
- K101586: Xtra Autotransfusion System (2010), cited by 4
- K943934: Aortic Arch Cannulas (1995), cited by 4
- K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir (2012), cited by 3

## Recent decisions
- K263092: Dual Stage Venous Cannulae (Oct 1, 2026)
- K262052: Tri Stage Venous Cannulae (Sep 28, 2026)
- K253671: Dual Stage Venous Cannulae (Jan 30, 2026)
- K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs (Dec 22, 2025)
- K253616: ProtekDilate Vascular Access Kit (Dec 19, 2025)
- K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (Jun 27, 2025)
- K250150: VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) (May 30, 2025)
- K243264: DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (Apr 25, 2025)

Source page: https://510kreport.com/company/sorin-group-italia