FDA applicant
Shantou Wealy Medical Instrument Co.,Ltd
FDA records 6 decisions for Shantou Wealy Medical Instrument Co.,Ltd (Shantou, CN) from 2012 to 2022: 6 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and PNR (Enteral Syringes With Enteral Specific…). Since 2016 its 510(k)s took a median of 241 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 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 Wealy Medical Instrument Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Shantou Wealy Medical Instrument Co.,Ltd’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”
FDA records each applicant name separately; these may or may not be the same firm.