FDA applicant
Caristo Diagnostics, Ltd.
FDA records 3 decisions for Caristo Diagnostics, Ltd. (Oxford, GB) from 2020 to 2026: 2 510(k) clearances and 1 De Novo grant. Most are in product codes LLZ (System, Image Processing, Radiological) and SIU (Predictive Indicator For Long-Term…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Caristo Diagnostics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Caristo Diagnostics, 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 Caristo Diagnostics, 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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