FDA applicant
Stepone Fertility Ltd (T/A Béa Fertility)
FDA records 1 decision for Stepone Fertility Ltd (T/A Béa Fertility) (London, GB) in 2025: 1 510(k) clearance. All are in product code HDR (Cap, Cervical). Its devices cite 1 predicate, 0 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 Stepone Fertility Ltd (T/A Béa Fertility)’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 2025.
Planning a device like Stepone Fertility Ltd (T/A Béa…’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