FDA applicant
Shandong Lianfa Medical Plastic Products Co., Ltd.
FDA records 2 decisions for Shandong Lianfa Medical Plastic Products Co., Ltd. (Jinan, CN) in 2022: 2 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and QRL (Multiple Use Blood Lancet For Single Patient…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shandong Lianfa Medical Plastic Products 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
1in 2025
Class I Class II/III not classified
Planning a device like Shandong Lianfa Medical Plastic…’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