FDA applicant
Sorin Group Italia S.R.L.
FDA records 63 decisions for Sorin Group Italia S.R.L. (Mirandola, IT) from 1995 to 2026: 63 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 92 predicates, 40 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sorin Group Italia S.R.L.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
2in 2018
Class I Class II/III not classified
Planning a device like Sorin Group Italia S.R.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sorin”
FDA records each applicant name separately; these may or may not be the same firm.