FDA applicant
Ultromics Limited
FDA records 6 decisions for Ultromics Limited (Oxford, GB) from 2019 to 2024: 6 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and QUO (Adjunctive Heart Failure Status Indicator). Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ultromics, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ultromics Limited’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 2019.
Planning a device like Ultromics Limited’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