FDA applicant
B-Secur Limited
FDA records 2 decisions for B-Secur Limited (Belfast, GB) from 2020 to 2024: 2 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DPS (Electrocardiograph). 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 “B-Secur , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided B-Secur Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like B-Secur 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