Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Iol, Inc. — 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) |
|---|---|---|---|---|---|
| K001768 | OCCU-FLO PUNCTUM PLUGS | U.S. Iol, Inc. | 2000-09-19 | 99 | 0 |
| K954746 | PHACO TIP | U.S. Iol, Inc. | 1996-01-11 | 87 | 0 |
| K954239 | U.S. IOL PHACO HANDPIECE | U.S. Iol, Inc. | 1995-12-08 | 88 | 0 |
| K954240 | EVOLUTION PHACOMULSIFIER | U.S. Iol, Inc. | 1995-12-01 | 81 | 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