FDA applicant
Cosmo Artificial Intelligence - Ai, Ltd.
FDA records 6 decisions for Cosmo Artificial Intelligence - Ai, Ltd. (Dublin, IE) from 2021 to 2026: 5 510(k) clearances and 1 De Novo grant. All are in product code QNP (Gastrointesinal Lesion Software Detection System). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 5 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 Cosmo Artificial Intelligence - Ai, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Cosmo Artificial Intelligence - Ai, 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) ReportOther applicant names beginning “Cosmo”
FDA records each applicant name separately; these may or may not be the same firm.