Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Taewoong Medical Co., Ltd. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
204 daysmedian FDA review time
342 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | 2026-05-21 | 59 | 0 |
| K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | 2026-03-13 | 204 | 0 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025-12-29 | 262 | 0 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2025-10-30 | 342 | 0 |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2025-03-31 | 26 | 0 |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023-06-14 | 264 | 0 |
| K223626 | Niti-S Biliary Speed D Stent | Taewoong Medical Co., Ltd. | 2023-05-26 | 172 | 0 |
| K223256 | Optimos™ Cystotome | Taewoong Medical Co., Ltd. | 2023-04-05 | 166 | 0 |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022-06-22 | 30 | 0 |
| K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2022-06-09 | 58 | 0 |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021-10-08 | 127 | 0 |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2013-10-09 | 362 | 0 |
| K113551 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2012-02-14 | 75 | 0 |
| K080782 | NITI-S ESOPHAGEAL STENT | Taewoong Medical Co., Ltd. | 2009-01-30 | 317 | 0 |
| K073667 | NITI-S BILIARY STENT | Taewoong Medical Co., Ltd. | 2008-11-19 | 329 | 0 |
| K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX | Taewoong Medical Co., Ltd. | 2005-04-28 | 315 | 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