Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Edwards Lifesciences Research Medical · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
227 daysmedian FDA review time
383 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIA | Edwards Lifesciences Research Medical | 2008-01-31 | 43 | 2 |
| K062429 | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, | Edwards Lifesciences Research Medical | 2006-09-27 | 37 | 0 |
| K990396 | T-ANASTAFLO | Edwards Lifesciences Research Medical | 1999-10-01 | 234 | 1 |
| K991170 | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODE | Edwards Lifesciences Research Medical | 1999-07-02 | 86 | 0 |
| K983791 | PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA | Edwards Lifesciences Research Medical | 1999-06-11 | 227 | 0 |
| K974259 | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS | Edwards Lifesciences Research Medical | 1998-12-01 | 383 | 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