Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
INTEROJO, 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) |
|---|---|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrog | INTEROJO, Inc. | 2026-05-29 | 101 | 0 |
| K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE | INTEROJO, Inc. | 2022-10-04 | 132 | 0 |
| K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens fo | INTEROJO, Inc. | 2016-04-08 | 100 | 0 |
| K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for D | INTEROJO, Inc. | 2015-03-12 | 168 | 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