FDA applicant
Shanghai Kindly Enterprise Development Group Co., Ltd.
FDA records 2 decisions for Shanghai Kindly Enterprise Development Group Co., Ltd. (Shanghai, CN) in 2023: 2 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Its devices cite 2 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 Shanghai Kindly Enterprise Development Group Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Shanghai Kindly Enterprise Development…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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