Menicon Co, Ltd.: FDA clearances and approvals
Menicon Co, Ltd. has 19 FDA 510(k) clearances (first 1994, latest 2026), plus 2 PMA decisions, across 5 product codes in 1 review panel. Median 510(k) review time: 100 days. Since 2017 its median was 59 days, against 108 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 128 |
| 2014 | 0 | — |
| 2015 | 1 | 59 |
| 2016 | 0 | — |
| 2017 | 1 | 48 |
| 2018 | 2 | 50 |
| 2019 | 0 | — |
| 2020 | 2 | 214 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 158 |
Review time against the same product codes
Since 2017, Menicon Co, Ltd.'s cleared 510(k)s took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 6 | 6 |
| HQD | Lens, Contact (Other Material) - Daily | 5 | 5 |
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
| LPN | Accessories, Soft Lens Products | 3 | 3 |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | 2 | 0 |
Review panels
- Ophthalmic (21)
Most recent Menicon Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262495 | Miru 1day UpSide (midafilcon A) | LPL | 2026-09-17 | 59 |
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | LPN | 2026-08-13 | 258 |
| K193399 | Miru 1day UpSide (midafilcon A) | LPL | 2020-06-17 | 194 |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | LPN | 2020-03-02 | 234 |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | LPL | 2018-05-16 | 48 |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | LPL | 2018-02-22 | 51 |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | MRC | 2017-11-16 | 48 |
| K151768 | Menicon Saline Rinse Solution | LPN | 2015-08-28 | 59 |
| K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | MRC | 2013-07-03 | 100 |
| K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | MRC | 2013-01-02 | 156 |
9 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990018 | PMA | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | 2000-07-11 |
| P880098 | PMA | MENICON SF-P RGP (MELAFOCON A) CONTACT LENS | 1989-09-01 |
Recalls
openFDA lists no recalls under a recalling firm named Menicon Co, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Menicon Co, Ltd. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06037850: Clinical Trial of Orthokeratology Lens (MCOK-01) (Completed, started 2022-07-29)
- NCT04299243: Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Completed, started 2018-11-25)
- NCT03454542: Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (Completed, started 2018-02-14)
- NCT04806763: Myopia Control With Orthokeratology Contact Lenses in Spain (Completed, started 2007-03-01)
- NCT04806711: Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children (Completed, started 2007-03-01)
Frequently asked questions
How many FDA 510(k) clearances does Menicon Co, Ltd. have?
Menicon Co, Ltd. has 19 FDA 510(k) clearances (first 1994, latest 2026), plus 2 PMA decisions, across 5 product codes in 1 review panel.
How long does FDA take to clear Menicon Co, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Menicon Co, Ltd.'s cleared 510(k)s is 100 days. Since 2017: 59 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does Menicon Co, Ltd. make?
Its most frequent FDA product codes are MRC (Products, Contact Lens Care, Rigid Gas Permeable, 6); HQD (Lens, Contact (Other Material) - Daily, 5); LPL (Lenses, Soft Contact, Daily Wear, 5).
Has Menicon Co, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Menicon Co, Ltd. Related entities may recall under other names.
Next steps
- See all 19 Menicon Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MRC, Menicon Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.