510(k) · Cleared
ClearedNiti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taewoong Medical Co., Ltd. · MUM Stent, Metallic, Expandable, Duodenal
Cleared on Mar 31, 2025 as substantially equivalent to K223067 (Taewoong Medical Co., Ltd., 2023) after a 26-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Mar 31, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- MUM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000281 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 6 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 5 generations backK061877 Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006
- 4 generations backK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
- 3 generations backK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
- 2 generations backK190141 HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019
- 1 generation backK223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2023
- This deviceK250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −6 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −5 | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery System | Boston Scientific Corp | 2006 | — |
| −4 | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus… | M.I.Tech Co., Ltd. | 2018 | — |
| −3 | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| −2 | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| −1 | K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023 | — |
| 0 (this device) | K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUM device
- #1 K223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort…score 10.0 · 6 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All MUM devicesMUM Stent, Metallic, Expandable, Duodenal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MUM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUM
Too few MUM 510(k)s in any year since 2007 to give a median.
Recalls per year · MUM
No recall names MUM since 2007.
Adverse event reports per year · MUM
32in 2025
MAUDE reports naming product code MUM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 102 |
| 2011 | 1 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 71 |
| 2013 | 0 | — | 0 | 62 |
| 2014 | 0 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 41 |
| 2017 | 1 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 70 |
| 2022 | 0 | — | 0 | 28 |
| 2023 | 1 | — | 0 | 53 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250663: Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250663
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026