Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clearlab Pte , Ltd. — 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) |
|---|---|---|---|---|---|
| K052290 | AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONT | Clearlab Pte , Ltd. | 2006-05-15 | 265 | 0 |
| K030748 | AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VIS | Clearlab Pte , Ltd. | 2003-05-14 | 65 | 0 |
| K030167 | MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBI | Clearlab Pte , Ltd. | 2003-04-02 | 76 | 0 |
| K003833 | SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC | Clearlab Pte , Ltd. | 2001-02-13 | 64 | 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