FDA applicant
Scopio Labs, Ltd.
FDA records 4 decisions for Scopio Labs, Ltd. (Tel Aviv, IL) from 2020 to 2025: 3 510(k) clearances and 1 De Novo grant. Most are in product codes JOY (Device, Automated Cell-Locating) and SAL (Device, Automated Cell Locating, Bone Marrow). Its devices cite 4 predicates, 3 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 Scopio Labs, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Scopio Labs, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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