Atlas FDA

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

The Orvis Co., Inc. — Predicate Candidate Screening

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

40 daysmedian FDA review time
80 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950609ORVIS KEY WEST SUNGLASSESThe Orvis Co., Inc.1995-03-02200
K943161ORVIS DRIVING GLASSESThe Orvis Co., Inc.1994-08-04340
K943131ORVIS POLARIZED BI-FOCALSThe Orvis Co., Inc.1994-08-02340
K942951ORVIS LIGHT WEIGHT POLARIZED CLIP-ONSThe Orvis Co., Inc.1994-08-02400
K942952ORVIS WORLD FINEST POLARIZED CLIP ONSThe Orvis Co., Inc.1994-07-25320
K941910SUNGLASSESThe Orvis Co., Inc.1994-07-08800
K941751SUNGLASSESThe Orvis Co., Inc.1994-06-03560
K940354ORVIS MARQUESAS FISHING GLASSESThe Orvis Co., Inc.1994-03-24580
K940292ORVIS RIVER GUIDE GLASSESThe Orvis Co., Inc.1994-03-24620

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