FDA applicant
Shanghai Microport EP Medtech Co., Ltd.
FDA records 4 decisions for Shanghai Microport EP Medtech Co., Ltd. (Shanghai, CN) in 2022: 4 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DRC (Trocar). Since 2016 its 510(k)s took a median of 267 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Shanghai Microport EP Medtech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Shanghai Microport EP Medtech 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