M.I.Tech Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “M.I.Tech Co., Ltd.” (first 2008, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 159 days. Since 2017 the median was 58 days, against 140 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 | 118 |
| 2017 | 0 | — |
| 2018 | 1 | 283 |
| 2019 | 3 | 37 |
| 2020 | 2 | 137 |
| 2021 | 3 | 223 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name M.I.Tech Co., Ltd. took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | 6 | 6 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
| MQR | Stent, Colonic, Metallic, Expandable | 3 | 3 |
| JCT | Prosthesis, Tracheal, Expandable | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
- Gastroenterology and Urology (12)
- Anesthesiology (1)
- Neurology (1)
Most recent M.I.Tech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | ESW | 2025-10-30 | 30 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | ESW | 2021-11-18 | 49 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | ESW | 2021-07-23 | 449 |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | FGE | 2021-05-11 | 223 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | JCT | 2020-12-31 | 225 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | ESW | 2020-05-20 | 49 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | MQR | 2019-03-07 | 37 |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | FGE | 2019-02-11 | 66 |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | MQR | 2019-01-10 | 15 |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | MQR | 2018-11-02 | 283 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named M.I.Tech 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 M.I.Tech Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “M.I.Tech Co., Ltd.” (first 2008, latest 2025), across 5 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 M.I.Tech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name M.I.Tech Co., Ltd. is 159 days. Since 2017: 58 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under M.I.Tech Co., Ltd.?
The most frequent FDA product codes under this applicant name are ESW (Prosthesis, Esophageal, 6); FGE (Stents, Drains And Dilators For The Biliary Ducts, 3); MQR (Stent, Colonic, Metallic, Expandable, 3).
Next steps
- See all 14 M.I.Tech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ESW, M.I.Tech 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.