FDA applicant
Guangzhou Fortunique, Ltd.
FDA records 1 decision for Guangzhou Fortunique, Ltd. (Chester, NY) in 2004: 1 510(k) clearance. All are in product code MMP (Cover, Barrier, Protective). Its devices cite 6 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Guangzhou Fortunique, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Guangzhou Fortunique, Ltd. since 2007.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Guangzhou Fortunique, 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) Report