Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cl-Tinters · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010126 | PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT L | Cl-Tinters | 2001-03-12 | 55 | 0 |
| K984259 | PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WE | Cl-Tinters | 1999-01-21 | 52 | 0 |
| K982774 | SOFT (HYDROPHILIC) CONTACT LENSES | Cl-Tinters | 1998-09-02 | 26 | 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