FDA applicant
Novate Medical, Ltd.
FDA records 3 decisions for Novate Medical, Ltd. (Galway, IE) from 2017 to 2018: 3 510(k) clearances. All are in product code DTK (Filter, Intravascular, Cardiovascular). Its devices cite 4 predicates, 2 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 Novate Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2017high 2 (2018) · low 0 (2019)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Novate Medical, Ltd.’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