Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Qualimed Srl · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181050 | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact | Qualimed Srl | 2018-06-13 | 54 | 0 |
| K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Qualimed Srl | 2014-12-12 | 108 | 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