Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ocu-Ease Optical Products, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
171 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023077 | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONT | Ocu-Ease Optical Products, Inc. | 2002-12-10 | 85 | 0 |
| K020690 | OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LEN | Ocu-Ease Optical Products, Inc. | 2002-04-26 | 53 | 0 |
| K011577 | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORI | Ocu-Ease Optical Products, Inc. | 2001-06-19 | 28 | 0 |
| K004000 | OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL ( | Ocu-Ease Optical Products, Inc. | 2001-02-21 | 57 | 0 |
| K003996 | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL ( | Ocu-Ease Optical Products, Inc. | 2001-02-21 | 57 | 0 |
| K002966 | OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICA | Ocu-Ease Optical Products, Inc. | 2000-11-08 | 47 | 0 |
| K992466 | OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DA | Ocu-Ease Optical Products, Inc. | 1999-10-04 | 73 | 0 |
| K960291 | TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT L | Ocu-Ease Optical Products, Inc. | 1996-03-25 | 63 | 0 |
| K941998 | OCU-FLEX-38 (POLYMACON) | Ocu-Ease Optical Products, Inc. | 1994-10-13 | 171 | 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