Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Vision Care, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
98 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | Johnson & Johnson Vision Care, Inc. | 2021-11-29 | 245 | 1 |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Johnson & Johnson Vision Care, Inc. | 2020-03-17 | 46 | 0 |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | Johnson & Johnson Vision Care, Inc. | 2018-04-10 | 67 | 0 |
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2016-03-28 | 59 | 0 |
| K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | Johnson & Johnson Vision Care, Inc. | 2014-09-18 | 87 | 0 |
| K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH | Johnson & Johnson Vision Care, Inc. | 2010-05-21 | 98 | 0 |
| K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | Johnson & Johnson Vision Care, Inc. | 2008-03-03 | 82 | 0 |
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEA | Johnson & Johnson Vision Care, Inc. | 2006-11-01 | 57 | 2 |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY | Johnson & Johnson Vision Care, Inc. | 2005-08-12 | 30 | 1 |
| K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS | Johnson & Johnson Vision Care, Inc. | 2003-10-16 | 79 | 0 |
| K024177 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONT | Johnson & Johnson Vision Care, Inc. | 2003-01-22 | 35 | 0 |
| K010114 | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER T | Johnson & Johnson Vision Care, Inc. | 2001-04-11 | 85 | 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