FDA applicant
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
FDA records 4 decisions for Shenzhen Ant Hi-Tech Industrial Co., Ltd. (Shanghai, CN) from 2008 to 2014: 4 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 4 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 Ant Hi-Tech Industrial Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Shenzhen Ant Hi-Tech Industrial 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) Report