Huvitz Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Huvitz Co., Ltd.” (first 2008, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 142 days, against 136 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 275 |
| 2018 | 0 | — |
| 2019 | 1 | 30 |
| 2020 | 0 | — |
| 2021 | 1 | 188 |
| 2022 | 0 | — |
| 2023 | 1 | 96 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Huvitz Co., Ltd. took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| NFJ | System, Image Management, Ophthalmic | 2 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HKY | Tonometer, Manual | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Huvitz Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232143 | Applanation Tonometer HT-5000 | HKY | 2023-10-23 | 96 |
| K202097 | Fundus Camera | HKI | 2021-02-02 | 188 |
| K191615 | Huvitz Imaging System | NFJ | 2019-07-18 | 30 |
| K161829 | Huvitz Imaging System | NFJ | 2017-04-06 | 275 |
| K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | HJO | 2009-12-03 | 9 |
| K073190 | SLIT LAMP | HJO | 2008-01-11 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Huvitz Co., Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Huvitz Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Huvitz Co., Ltd.” (first 2008, latest 2023), across 4 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 Huvitz Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Huvitz Co., Ltd. is 78 days. Since 2017: 142 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Huvitz Co., Ltd.?
The most frequent FDA product codes under this applicant name are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 2); NFJ (System, Image Management, Ophthalmic, 2); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Next steps
- See all 6 Huvitz Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HJO, Huvitz Co., Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.