Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Togo Medikit Co., Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
265 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1 | Togo Medikit Co., Ltd. | 2024-09-17 | 138 | 0 |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020-03-19 | 30 | 0 |
| K190001 | Supercath 5 | Togo Medikit Co., Ltd. | 2019-09-20 | 261 | 0 |
| K172496 | SUPERCATH 5 (26G) | Togo Medikit Co., Ltd. | 2018-03-23 | 217 | 0 |
| K160592 | SUPERCATH 6 | Togo Medikit Co., Ltd. | 2016-08-12 | 164 | 0 |
| K141070 | SUPER SHEATH | Togo Medikit Co., Ltd. | 2015-01-15 | 265 | 0 |
| K140419 | SUPERCATH5 | Togo Medikit Co., Ltd. | 2014-05-12 | 83 | 0 |
| K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER S | Togo Medikit Co., Ltd. | 2012-09-27 | 129 | 0 |
| K112290 | SUPERCATH Z3V | Togo Medikit Co., Ltd. | 2012-04-16 | 251 | 0 |
| K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009-12-17 | 30 | 0 |
| K081953 | SUPERCATH 5 | Togo Medikit Co., Ltd. | 2009-03-12 | 246 | 0 |
| K052267 | SUPERCATH V | Togo Medikit Co., Ltd. | 2006-10-27 | 434 | 0 |
| K060190 | SUPER SHEATH XL INTRODUCER SHEATH | Togo Medikit Co., Ltd. | 2006-04-04 | 70 | 0 |
| K052557 | SUPER SHEATH INTRODUCER SHEATH | Togo Medikit Co., Ltd. | 2006-01-17 | 123 | 1 |
| K050114 | SUPERCATH Z3V | Togo Medikit Co., Ltd. | 2005-06-09 | 142 | 0 |
| K864038 | SUPERCATH I.V. CATHETER | Togo Medikit Co., Ltd. | 1986-12-04 | 49 | 0 |
| K854773 | SUPERCATH A.V. FISTULA | Togo Medikit Co., Ltd. | 1986-04-08 | 130 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda