FDA applicant
Iline Microsystems, S.L.
FDA records 5 decisions for Iline Microsystems, S.L. (San Sebastian-Donostia, ES) from 2019 to 2025: 5 510(k) clearances. All are in product code GJS (Test, Time, Prothrombin). Its devices cite 8 predicates, 7 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 Iline Microsystems, S.L.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Iline Microsystems, S.L.’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