Atlas FDA

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

Ocular Sciences Puerto Rico, Inc. — Predicate Candidate Screening

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

74 daysmedian FDA review time
161 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013377BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACTOcular Sciences Puerto Rico, Inc.2001-12-20690
K012425BIOMEDICS UV MULTIFOCALOcular Sciences Puerto Rico, Inc.2001-10-12740
K003136OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKINGOcular Sciences Puerto Rico, Inc.2001-01-06920
K992264OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKINOcular Sciences Puerto Rico, Inc.1999-11-241410
K982947BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) COOcular Sciences Puerto Rico, Inc.1999-01-291610
K984046BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) COOcular Sciences Puerto Rico, Inc.1999-01-21700
K972303OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTAOcular Sciences Puerto Rico, Inc.1997-08-20620

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