Johnson & Johnson Vision Care, Inc.: FDA filings under this applicant name

FDA lists 12 510(k) clearances under the applicant name “Johnson & Johnson Vision Care, Inc.” (first 2001, latest 2021), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 73 days. Since 2017 the median was 67 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Johnson & Johnson Vision Care, Inc. took a median 67 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.

Top product codes

Review panels

• Ophthalmic (13)

Most recent Johnson & Johnson Vision Care, Inc. 510(k) clearances

2 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

11 product recalls in 8 recall events; 1 initiated in the last five years. Most recent: 2025-06-12.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Johnson & Johnson Vision Care, Inc. is the lead sponsor of 199 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:

• NCT07443215: Evaluation of Effect of Scatter on Visual Performance (Recruiting, started 2026-02-13)
• NCT07174596: Evaluation of Approved Contact Lenses (Completed, started 2025-09-11)
• NCT07076160: Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses (Completed, started 2025-07-24)
• NCT06967129: Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process (Completed, started 2025-04-25)
• NCT06864858: Clinical Evaluation of Two Cosmetic Contact Lenses (Completed, started 2025-03-30)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Johnson & Johnson Professionals, Inc. (206 510(k)s)
• Johnson & Johnson Medical, Inc. (56 510(k)s)
• Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
• Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
• Johnson & Johnson (10 510(k)s)
• Johnson & Johnson International (10 510(k)s)
• Johnson & Johnson Consumer Products, Inc. (8 510(k)s)
• Johnson & Johnson Medical, Div. of Ethicon, Inc. (5 510(k)s)
• Johnson & Johnson Surgical Vision, Inc. (4 510(k)s)
• Johnson & Johnson Patient Care, Inc. (4 510(k)s)
• Johnson and Johnson (2 510(k)s)
• Johnson & Johnson Company (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Johnson & Johnson Vision Care, Inc.?

FDA lists 12 510(k) clearances under the applicant name “Johnson & Johnson Vision Care, Inc.” (first 2001, latest 2021), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Johnson & Johnson Vision Care, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Vision Care, Inc. is 73 days. Since 2017: 67 days, versus 111 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Johnson & Johnson Vision Care, Inc.?

The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 11); LPM (Lenses, Soft Contact, Extended Wear, 1); MVN (Lens, Contact, (Disposable), 1).

Next steps

• See all 12 Johnson & Johnson Vision Care, Inc. clearances with predicates and recalls
• Run predicate analysis for product code LPL, Johnson & Johnson Vision Care, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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