Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fenwal, Inc. — 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) |
|---|---|---|---|---|---|
| K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | Fenwal, Inc. | 2014-06-10 | 50 | 0 |
| K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE | Fenwal, Inc. | 2012-03-22 | 279 | 1 |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND | Fenwal, Inc. | 2008-03-03 | 96 | 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