Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A-Med Systems, Inc. · 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) |
|---|---|---|---|---|---|
| K020529 | LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 | A-Med Systems, Inc. | 2002-08-26 | 188 | 0 |
| K013393 | HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODE | A-Med Systems, Inc. | 2001-11-09 | 25 | 0 |
| K992592 | A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 | A-Med Systems, Inc. | 2000-05-04 | 276 | 0 |
| K991541 | A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10- | A-Med Systems, Inc. | 1999-12-28 | 239 | 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