FDA applicant
Promisemed Hangzhou Meditech Co., Ltd.
FDA records 36 decisions for Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN) from 2017 to 2026: 36 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 18 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 Promisemed Hangzhou Meditech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Promisemed Hangzhou Meditech 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