Atlas FDA

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

Polymer Technology · Predicate Candidate Screening

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

62 daysmedian FDA review time
120 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003933BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATPolymer Technology2001-02-16580
K003932BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGYPolymer Technology2001-02-16580
K002025RIGID GAS PERMEABLE CONTACT LENSPolymer Technology2000-10-311200
K001960RIGID GAS PERMEABLE CONTACT LENSPolymer Technology2000-08-28620
K000795RIGID GAS PERMEABLE CONTACT LENSPolymer Technology2000-05-26740

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