Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUM · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
143 daysmedian FDA review time
299 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| 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 |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colon | Cook Ireland, Ltd. | 2017-05-04 | 143 | 0 |
| K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22 | Cook Ireland, Ltd. | 2011-03-29 | 299 | 0 |
| K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SY | Boston Scientific Corp | 2006-12-04 | 81 | 0 |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-04-03 | 80 | 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