Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sunsoft Corp. · 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) |
|---|---|---|---|---|---|
| K964696 | SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTAC | Sunsoft Corp. | 1997-02-20 | 90 | 1 |
| K942374 | ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT | Sunsoft Corp. | 1995-04-13 | 330 | 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