FDA applicant
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
FDA records 8 decisions for Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (Shantou, CN) from 2016 to 2021: 8 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 52 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)’s devices, and how often a recall has named them.
FDA decisions per year
3in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Shantou Institute of Ultrasonic…’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 “Shantou”
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