FDA applicant
Speciality Fibres and Materials, Ltd.
FDA records 3 decisions for Speciality Fibres and Materials, Ltd. (Coventry, GB) from 2019 to 2026: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Speciality Fibres and Materials Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Speciality Fibres and Materials, Ltd.’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 2019.
Planning a device like Speciality Fibres and Materials, 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) Report