FDA applicant
Shenzhen Insighters Medical Technology Co., Ltd.
FDA records 3 decisions for Shenzhen Insighters Medical Technology Co., Ltd. (Shenzhen, CN) from 2023 to 2025: 3 510(k) clearances. Most are in product codes CBI (Tube, Tracheal/Bronchial, Differential…) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 3 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 Insighters Medical Technology 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 2023.
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