Nidek Technologies Srl: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nidek Technologies Srl” (first 2001, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 169 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 4 | 4 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Nidek Technologies Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX | HKI | 2012-05-08 | 169 |
| K070231 | ORION | HKI | 2007-04-24 | 90 |
| K061768 | MP-1 MICROPERIMETER | HKI | 2006-09-28 | 97 |
| K023719 | MP-1 MICRO PERIMETER | HKI | 2002-12-23 | 48 |
| K012416 | CONFOSCAN 2 CONFOCAL MICROSCOPE | HJO | 2001-10-26 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Nidek Technologies Srl.
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.
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.
- Nidek, Inc. (97 510(k)s)
- Nidek Medical Products, Inc. (12 510(k)s)
- Nidek Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nidek Technologies Srl?
FDA lists 5 510(k) clearances under the applicant name “Nidek Technologies Srl” (first 2001, latest 2012), across 2 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 Nidek Technologies Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nidek Technologies Srl is 90 days.
Which FDA product codes appear under Nidek Technologies Srl?
The most frequent FDA product codes under this applicant name are HKI (Camera, Ophthalmic, Ac-Powered, 4); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 1).
Next steps
- See all 5 Nidek Technologies Srl clearances with predicates and recalls
- Run predicate analysis for product code HKI, Nidek Technologies Srl'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.