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

Precision-Cosmet Co., Inc. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861057MANUAL OPHTHALMIC SURGICAL INSTRUMENTSPrecision-Cosmet Co., Inc.1986-04-24360
K852934PRECISION - COSMET CAPSULE COUPEURPrecision-Cosmet Co., Inc.1985-08-08300
K840204WHITE OCULAR PRESSURE RELIEF DEVICEPrecision-Cosmet Co., Inc.1985-02-153930
K840104PETRUS IOL GUIDEPrecision-Cosmet Co., Inc.1984-04-241050

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