FDA applicant
Terumo Europe N.V.
FDA records 28 decisions for Terumo Europe N.V. (Leuven, BE) from 1999 to 2025: 28 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 181 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 50 predicates, 32 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terumo Europe N.V.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Terumo Europe N.V.’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 “Terumo”
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