FDA applicant
S.A.L.F. Spa
FDA records 6 decisions for S.A.L.F. Spa (Cenate Sotto, IT) from 2017 to 2023: 6 510(k) clearances. Most are in product codes KDN (System, Perfusion, Kidney) and KDL (Set, Perfusion, Kidney, Disposable). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided S.A.L.F. Spa’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like S.A.L.F. Spa’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) Report