Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Itl Corporation Pty, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
204 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153472 | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | 2016-06-23 | 204 | 0 |
| K021941 | SAMPLOK LUER KIT | Itl Corporation Pty, Ltd. | 2002-07-02 | 19 | 0 |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Itl Corporation Pty, Ltd. | 2002-06-19 | 82 | 0 |
| K000777 | SAMPLOK | Itl Corporation Pty, Ltd. | 2000-04-11 | 33 | 0 |
| K991404 | PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) | Itl Corporation Pty, Ltd. | 1999-05-14 | 22 | 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