FDA applicant
Simplivia Healthcare, Ltd.
FDA records 6 decisions for Simplivia Healthcare, Ltd. (Kiryat Shmona, IL) from 2020 to 2025: 6 510(k) clearances. All are in product code ONB (Closed Antineoplastic And Hazardous Drug…). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Simplivia Healthcare, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Simplivia Healthcare, 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