Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MicroPort NeuroTech (Shanghai) Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260351 | Numen™ Helia Coil Embolization System; NumenFR™ Detachment S | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 | 106 | 0 |
| K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 | 69 | 0 |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 | 111 | 0 |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021-09-01 | 264 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda