Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Westcon Contact Lens Co., Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
256 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | Westcon Contact Lens Co., Inc. | 2005-02-01 | 41 | 0 |
| K031774 | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT | Westcon Contact Lens Co., Inc. | 2004-02-20 | 256 | 0 |
| K023530 | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) | Westcon Contact Lens Co., Inc. | 2002-11-26 | 36 | 0 |
| K992010 | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK | Westcon Contact Lens Co., Inc. | 1999-06-29 | 14 | 0 |
| K963837 | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORI | Westcon Contact Lens Co., Inc. | 1996-12-20 | 87 | 0 |
| K962121 | HORIZON/WESTHIN 55-G | Westcon Contact Lens Co., Inc. | 1996-08-26 | 87 | 0 |
| K954524 | W-55 (METHAFILON A) CONTACT LENS | Westcon Contact Lens Co., Inc. | 1996-03-28 | 181 | 0 |
| K950818 | HORIZON 55 BI-CON TORIC | Westcon Contact Lens Co., Inc. | 1995-03-21 | 26 | 0 |
| K945365 | HORIZON 55 BI-CON | Westcon Contact Lens Co., Inc. | 1994-12-28 | 56 | 0 |
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