Takagi Seiko Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Takagi Seiko Co., Ltd.” (first 2007, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 127 days. Since 2017 the median was 90 days, against 151 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 | 1 | 265 |
| 2017 | 2 | 120 |
| 2018 | 1 | 90 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Takagi Seiko Co., Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 3 | 3 |
| HKY | Tonometer, Manual | 2 | 2 |
Review panels
- Ophthalmic (5)
Most recent Takagi Seiko Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182491 | Applanation tonometer AT-2 | HKY | 2018-12-10 | 90 |
| K172728 | Applanation tonometer AT-1 | HKY | 2017-10-17 | 36 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | HJO | 2017-04-14 | 205 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | HJO | 2016-05-26 | 265 |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | HJO | 2007-03-13 | 127 |
Recalls
openFDA lists no recalls under a recalling firm named Takagi Seiko 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 Takagi Seiko Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Takagi Seiko Co., Ltd.” (first 2007, latest 2018), 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 Takagi Seiko Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Takagi Seiko Co., Ltd. is 127 days. Since 2017: 90 days, versus 151 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Takagi Seiko Co., Ltd.?
The most frequent FDA product codes under this applicant name are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 3); HKY (Tonometer, Manual, 2).
Next steps
- See all 5 Takagi Seiko Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HJO, Takagi Seiko 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, 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.