510(k) · Cleared
ClearedNiti-S Stent & Introducer, Model Eoxxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taewoong Medical Co., Ltd. · ESW Prosthesis, Esophageal
Cleared on Apr 28, 2005 as substantially equivalent to K032930 (Boston Scientific Corp, 2003) after a 315-day review. Its family tree reaches back 2 generations to 1996. 27 later devices descend from it.
- Decided
- Apr 28, 2005
- Review
- 315 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955347 (1996). 27 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK955347 UltraflexBoston Scientific Corp · 1996
- 1 generation backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
- This deviceK041648 Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005
- Descendant · cites it directly · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · cites it directly · 15 of its ownK080782 Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK111149 Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · cites it directly23descendants
- K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · cites it directly15descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 2 generations on10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 2 generations on9descendants
- K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955347 | Ultraflex | Boston Scientific Corp | 1996 | — |
| −1 | K032930 | Ultraflex Esophageal NG Stent System | Boston Scientific Corp | 2003 | 16 |
| 0 (this device) | K041648 | Niti-S Stent & Introducer, Model Eoxxxx | Taewoong Medical Co., Ltd. | 2005 | — |
| +1 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +1 | K080782 | Niti-S Esophageal Stent | Taewoong Medical Co., Ltd. | 2009 | 1 |
| +2 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +2 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| +2 | K111149 | Hanarostent Biliary (NNN) | M.I.Tech Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 ESW? 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 ESW device
- #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032930 | Ultraflex Esophageal NG Stent SystemSummary page 1…Product Code: ESW 3. Predicate Device: Ultraflex Esophageal NG Stent System, Boston scientific Corp, K032930 4. Description: Niti-S Esophageal Non-covered Stent & Introducer is a rigid, flexible, and ex… | 2003 |
What descends from it? (27)
See all 273 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K073667 (Taewoong Medical Co., Ltd., 2008) has gone furthest, with 23 descendants of its own.
- 6 other devices also cite its predicate K032930.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ESW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ESW
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ESW
25in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESW
120in 2025
MAUDE reports naming product code ESW, 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 | 88 |
| 2008 | 5 | 99 | 0 | 153 |
| 2009 | 3 | 35 | 0 | 239 |
| 2010 | 3 | 206 | 25 | 255 |
| 2011 | 1 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 121 |
| 2013 | 2 | — | 0 | 145 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 175 |
| 2016 | 1 | — | 0 | 153 |
| 2017 | 0 | — | 0 | 87 |
| 2018 | 2 | — | 0 | 86 |
| 2019 | 1 | — | 0 | 167 |
| 2020 | 1 | — | 0 | 155 |
| 2021 | 4 | 139 | 0 | 77 |
| 2022 | 1 | — | 0 | 109 |
| 2023 | 0 | — | 0 | 155 |
| 2024 | 4 | 130 | 0 | 166 |
| 2025 | 3 | 90 | 0 | 120 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041648: Niti-S Stent & Introducer, Model Eoxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041648
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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