Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M.I.Tech Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
423 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025-10-30 | 30 | 0 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021-11-18 | 49 | 0 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021-07-23 | 449 | 0 |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | 2021-05-11 | 223 | 0 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020-12-31 | 225 | 0 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS ( | M.I.Tech Co., Ltd. | 2020-05-20 | 49 | 0 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019-03-07 | 37 | 0 |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | M.I.Tech Co., Ltd. | 2019-02-11 | 66 | 0 |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duod | M.I.Tech Co., Ltd. | 2019-01-10 | 15 | 0 |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM | M.I.Tech Co., Ltd. | 2018-11-02 | 283 | 0 |
| K160893 | HANAROCare ReJu | M.I.Tech Co., Ltd. | 2016-07-27 | 118 | 0 |
| K111149 | HANAROSTENT BILIARY (NNN) | M.I.Tech Co., Ltd. | 2011-12-30 | 249 | 0 |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | M.I.Tech Co., Ltd. | 2010-06-04 | 200 | 0 |
| K072094 | CHOOSTENT | M.I.Tech Co., Ltd. | 2008-09-25 | 423 | 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