FDA applicant
Sofradim Production
FDA records 43 decisions for Sofradim Production (Trévoux, FR) from 1999 to 2026: 43 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and OTP (Mesh, Surgical, Synthetic, Urogynecologic, For…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 90 predicates, 60 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sofradim Production’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Sofradim Production’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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