Centervue S.P.A.: FDA clearances and approvals
Centervue S.P.A. has 13 FDA 510(k) clearances (first 2010, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time: 125 days. Since 2017 its median was 118 days, against 131 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 120 |
| 2015 | 1 | 141 |
| 2016 | 1 | 218 |
| 2017 | 0 | — |
| 2018 | 2 | 128 |
| 2019 | 1 | 102 |
| 2020 | 0 | — |
| 2021 | 2 | 68 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 245 |
| 2025 | 1 | 125 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Centervue S.P.A.'s cleared 510(k)s took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | 9 | 9 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 | 1 |
| NFJ | System, Image Management, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (13)
Most recent Centervue S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243504 | MAIA (AHMACME001) | MYC | 2025-03-17 | 125 |
| K234076 | iCare ALTIUS CW | NFJ | 2024-08-22 | 245 |
| K213705 | DRSplus | MYC | 2021-12-21 | 27 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | MYC | 2021-08-19 | 108 |
| K192113 | DRSplus | MYC | 2019-11-15 | 102 |
| K180526 | EIDON FA | MYC | 2018-07-16 | 139 |
| K180293 | Retia 2 | MYC | 2018-05-30 | 118 |
| K153181 | MAIA | MYC | 2016-06-08 | 218 |
| K150320 | COMPASS | MYC | 2015-06-30 | 141 |
| K142047 | EIDON | MYC | 2014-11-12 | 107 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Centervue S.P.A..
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.
Frequently asked questions
How many FDA 510(k) clearances does Centervue S.P.A. have?
Centervue S.P.A. has 13 FDA 510(k) clearances (first 2010, latest 2025), across 5 product codes in 1 review panel.
How long does FDA take to clear Centervue S.P.A.'s 510(k)s?
The median time from FDA receipt to decision across Centervue S.P.A.'s cleared 510(k)s is 125 days. Since 2017: 118 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Centervue S.P.A. make?
Its most frequent FDA product codes are MYC (Ophthalmoscope, Laser, Scanning, 9); HKI (Camera, Ophthalmic, Ac-Powered, 1); HLI (Ophthalmoscope, Ac-Powered, 1).
Has Centervue S.P.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Centervue S.P.A. Related entities may recall under other names.
Next steps
- See all 13 Centervue S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code MYC, Centervue S.P.A.'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.