Togo Medikit Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Togo Medikit Co., Ltd.” (first 1986, latest 2024), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 138 days. Since 2017 the median was 178 days, against 85 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 | 2 | 190 |
| 2013 | 0 | — |
| 2014 | 1 | 83 |
| 2015 | 1 | 265 |
| 2016 | 1 | 164 |
| 2017 | 0 | — |
| 2018 | 1 | 217 |
| 2019 | 1 | 261 |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 138 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Togo Medikit Co., Ltd. took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 85 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 9 | 9 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| FIE | Needle, Fistula | 2 | 2 |
Review panels
Most recent Togo Medikit Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 | DYB | 2024-09-17 | 138 |
| K200379 | Super Sheath | DRE | 2020-03-19 | 30 |
| K190001 | Supercath 5 | FOZ | 2019-09-20 | 261 |
| K172496 | SUPERCATH 5 (26G) | FOZ | 2018-03-23 | 217 |
| K160592 | SUPERCATH 6 | FOZ | 2016-08-12 | 164 |
| K141070 | SUPER SHEATH | DRE | 2015-01-15 | 265 |
| K140419 | SUPERCATH5 | FOZ | 2014-05-12 | 83 |
| K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS | DYB | 2012-09-27 | 129 |
| K112290 | SUPERCATH Z3V | FOZ | 2012-04-16 | 251 |
| K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX | FOZ | 2009-12-17 | 30 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Togo Medikit 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 Togo Medikit Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Togo Medikit Co., Ltd.” (first 1986, latest 2024), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Togo Medikit Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Togo Medikit Co., Ltd. is 138 days. Since 2017: 178 days, versus 85 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Togo Medikit Co., Ltd.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 9); DRE (Dilator, Vessel, For Percutaneous Catheterization, 3); DYB (Introducer, Catheter, 3).
Next steps
- See all 17 Togo Medikit Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Togo Medikit 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.