FDA applicant
Avenir Performance Europeenne Medical (Apem)
FDA records 3 decisions for Avenir Performance Europeenne Medical (Apem) (Château-Landon, FR) from 2019 to 2022: 3 510(k) clearances. All are in product code LHI (Set, I.V. Fluid Transfer). Since 2016 its 510(k)s took a median of 235 days from receipt to decision, against 247 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Avenir Performance Européenne Medical (Apem)”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Avenir Performance Europeenne Medical (Apem)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
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