Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flexlens, 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) |
|---|---|---|---|---|---|
| K970312 | CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) | Flexlens, Inc. | 1997-04-02 | 65 | 0 |
| K962000 | FLEXLENS(METHAFILCON A) | Flexlens, Inc. | 1996-10-01 | 132 | 0 |
| K961943 | FLEXLENS | Flexlens, Inc. | 1996-10-01 | 134 | 0 |
| K950294 | FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS | Flexlens, Inc. | 1996-04-11 | 442 | 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