Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zerusa Limited · 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) |
|---|---|---|---|---|---|
| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | 2010-05-21 | 30 | 2 |
| K092711 | GUARDIAN II HEMOSTASIS VALVE | Zerusa Limited | 2009-10-01 | 28 | 2 |
| K073620 | GUARDIAN HEMOSTASIS VALVE | Zerusa Limited | 2008-02-27 | 63 | 0 |
| K052381 | GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER | Zerusa Limited | 2005-11-21 | 83 | 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