FDA applicant
Shenzhen Bsx Technology Electronics Co., Ltd.
FDA records 5 decisions for Shenzhen Bsx Technology Electronics Co., Ltd. (Shenzhen, CN) from 2019 to 2025: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and OHT (Light Based Over-The-Counter Hair Removal). Since 2016 its 510(k)s took a median of 243 days from receipt to decision, against 142 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Shenzhen Bsx Technology Electronics Co., Ltd.’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 2019.
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