FDA applicant
Jiangsu Caina Medical Co.,Ltd
FDA records 21 decisions for Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN) from 2018 to 2024: 21 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and MEG (Syringe, Antistick). Since 2016 its 510(k)s took a median of 165 days from receipt to decision, against 189 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices, 4 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jiangsu Caina Medical Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
4in 2023
Class I Class II/III not classified
Planning a device like Jiangsu Caina 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