FDA applicant
Jiangxi Hongda Medical Equipment Group, Ltd.
FDA records 7 decisions for Jiangxi Hongda Medical Equipment Group, Ltd. (Nanchang, CN) from 2017 to 2021: 7 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Jiangxi Hongda Medical Equipment Group Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jiangxi Hongda Medical Equipment Group, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Jiangxi Hongda Medical Equipment…’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