Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Worldwide Surgical Gauze · 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) |
|---|---|---|---|---|---|
| K823455 | SURGICAL GAUZE | Worldwide Surgical Gauze | 1983-01-28 | 71 | 0 |
| K812572 | GAUZE SPONGES | Worldwide Surgical Gauze | 1981-11-02 | 54 | 0 |
| K803172 | GAUZE SPONGES | Worldwide Surgical Gauze | 1981-01-15 | 31 | 0 |
| K802429 | COTTON ROLLS | Worldwide Surgical Gauze | 1980-10-23 | 20 | 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