FDA applicant
Wuxi Hisky Medical Technologies Co., Ltd.
FDA records 5 decisions for Wuxi Hisky Medical Technologies Co., Ltd. (Wuxi, CN) from 2018 to 2025: 5 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 7 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 Wuxi Hisky Medical Technologies Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Wuxi Hisky Medical Technologies Co.…’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) ReportOther applicant names beginning “Wuxi”
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