510(k) · Cleared
ClearedNiti-S Duodenal 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 Jun 14, 2023 as substantially equivalent to K183616 (M.I.Tech Co., Ltd., 2019) and 1 other predicate after a 264-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Jun 14, 2023
- Review
- 264 days
- Class
- Class II
- Product code
- MUM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000281 (2000). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 5 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 4 generations backK061877 Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006
- 3 generations backK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
- 2 generations backK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
- 1 generation backK190141 HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019
- This deviceK223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −5 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −4 | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery System | Boston Scientific Corp | 2006 | — |
| −3 | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus… | M.I.Tech Co., Ltd. | 2018 | — |
| −2 | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| −1 | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| 0 (this device) | K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic…score 10.9 · 7 generations · no Class I recall
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)Summary page 4…ass II Product Codes: MUM (Niti-S Duodenal Comfort Stent) MQR (Niti-S Colonic Comfort Stent) 3. PREDICATE DEVICES K183616 M.I. Tech Co., Ltd, HANAROSTENT LowAx™ Duodenum/Pylorus K190141 M.I. Tech Co., Ltd, HANAROSTENT LowAx™ Col… | 2019 |
| * | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)Summary page 4…MQR (Niti-S Colonic Comfort Stent) 3. PREDICATE DEVICES K183616 M.I. Tech Co., Ltd, HANAROSTENT LowAx™ Duodenum/Pylorus K190141 M.I. Tech Co., Ltd, HANAROSTENT LowAx™ Colon/Rectum 4. DEVICE DESCRIPTION The Niti-S Duodenal Comfort Stent… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | 2025 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K250663 (Taewoong Medical Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183616.
How does its category compare?
All MUM devicesMUM Stent, Metallic, Expandable, Duodenal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The 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 as stated in the FDA summary.
https://510kreport.com/device/K223067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223067: Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223067
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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