Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MQR — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
102 daysmedian FDA review time
393 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery Syst | Boston Scientific Corporation | 2024-03-08 | 78 | 0 |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery Syst | Boston Scientific Corporation | 2020-08-17 | 109 | 0 |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery | Boston Scientific Corporation | 2020-04-17 | 74 | 0 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019-03-07 | 37 | 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 |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | Cook Ireland, Ltd. | 2012-05-17 | 171 | 0 |
| K061877 | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYS | Boston Scientific Corp | 2006-09-15 | 74 | 0 |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557 | Boston Scientific Corporation | 2006-05-12 | 92 | 1 |
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYS | Boston Scientific Corp | 2004-09-30 | 59 | 0 |
| K030769 | ULTRAFLEX PRECISION COLONIC STENT | Boston Scientific Corp | 2003-07-14 | 125 | 0 |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | 2000-05-12 | 102 | 0 |
| K990034 | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | 2000-04-17 | 467 | 0 |
| K990504 | MEMOTHERM COLORECTAL STENT | C.R. Bard, Inc. | 2000-03-16 | 393 | 0 |
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTE | Boston Scientific Corp | 1999-06-22 | 84 | 1 |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | 300 | 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