Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Edwards Lifesciences Services GmbH · 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) |
|---|---|---|---|---|---|
| K090682 | EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 | Edwards Lifesciences Services GmbH | 2009-11-19 | 248 | 0 |
| K070320 | EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 | Edwards Lifesciences Services GmbH | 2007-06-07 | 125 | 1 |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERIL | Edwards Lifesciences Services GmbH | 2007-03-23 | 142 | 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