Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai MicroPort Medical (Group) Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252116 | Firefighterâ„¢ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 | 274 | 0 |
| K223189 | Firefighterâ„¢ NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 | 282 | 0 |
| K143160 | FOXTROT NC PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2015-03-05 | 122 | 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