FDA applicant
Koo (Shanghai) Industries Co., Ltd.
FDA records 2 decisions for Koo (Shanghai) Industries Co., Ltd. (Bonita Springs, FL) in 2011: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and NVP (Holding Chambers, Direct Patient Interface). Its devices cite 3 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 Koo (Shanghai) Industries Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Koo (Shanghai) Industries 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) Report