Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Polycore Optical Pte , Ltd. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

126 daysmedian FDA review time
137 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832461POLYCOREPolycore Optical Pte , Ltd.1983-08-16210
K822430KRYPTOX-ROUND SEGMENT BIFOCALPolycore Optical Pte , Ltd.1982-12-271370
K822431SUNGLASS & SAFETY PLANO LENSPolycore Optical Pte , Ltd.1982-12-271370
K822542POLYCOREPolycore Optical Pte , Ltd.1982-12-271260
K822541VISIOPAL 75Polycore Optical Pte , Ltd.1982-12-271260
K822429SINGLE VISION POWER LENSPolycore Optical Pte , Ltd.1982-12-271370
K790215LENS, POLYCOREPolycore Optical Pte , Ltd.1979-02-26270

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