FDA applicant
Ningbo Medsun Medical Co., Ltd.
FDA records 7 decisions for Ningbo Medsun Medical Co., Ltd. (Ningbo, CN) from 2022 to 2026: 7 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 68 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 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 Ningbo Medsun Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Ningbo Medsun Medical 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