FDA applicant
B&E Korea Co., Ltd.
FDA records 1 decision for B&E Korea Co., Ltd. (Hwaseong-Si, KR) in 2024: 1 510(k) clearance. All are in product code ELW (Material, Impression). Its devices cite 2 predicates, 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 B&E Korea Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2024high 1 (2024) · low 0 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like B&E Korea Co., 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