FDA applicant
Shenzhen Wisonic Medical Technology Co., Ltd.
FDA records 7 decisions for Shenzhen Wisonic Medical Technology Co., Ltd. (Shenzhen, CN) from 2018 to 2023: 7 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 190 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 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 Wisonic Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
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