Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Lagado Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
426 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120756 | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, | The Lagado Corp. | 2013-05-13 | 426 | 0 |
| K130285 | PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERME | The Lagado Corp. | 2013-04-03 | 57 | 0 |
| K102154 | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE | The Lagado Corp. | 2011-01-21 | 175 | 0 |
| K052507 | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, | The Lagado Corp. | 2005-11-02 | 50 | 0 |
| K033599 | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHER | The Lagado Corp. | 2004-09-16 | 307 | 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