510(k) · Cleared
Recalled · Class II · 2019Niti-S Esophageal Stent
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 Jan 30, 2009 as substantially equivalent to K940838 (Boston Scientific Corp, 1994) and 2 other predicates after a 317-day review. Its family tree reaches back 3 generations to 1996. 15 later devices descend from it. It has been recalled once.
- Decided
- Jan 30, 2009
- Review
- 317 days
- Class
- Class II
- Product code
- ESW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955347 (1996). 7 ancestors in all, the oldest K920218 (1994). 15 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK955347 UltraflexBoston Scientific Corp · 1996
- 2 generations backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
- 1 generation backK041648 Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005
- This deviceK080782 Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009
- Descendant · cites it directly · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · cites it directly · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK211706 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- Descendant · 2 generations on · 2 of its ownK221482 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · cites it directly10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · cites it directly9descendants
- K211706Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021 · 2 generations on3descendants
- K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · 2 generations on3descendants
- K221482Esophageal TTS StentTaewoong Medical Co., Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955347 | Ultraflex | Boston Scientific Corp | 1996 | — |
| −2 | K032930 | Ultraflex Esophageal NG Stent System | Boston Scientific Corp | 2003 | 16 |
| −1 | K041648 | Niti-S Stent & Introducer, Model Eoxxxx | Taewoong Medical Co., Ltd. | 2005 | — |
| 0 (this device) | K080782 | Niti-S Esophageal Stent | Taewoong Medical Co., Ltd. | 2009 | — |
| +1 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +1 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| +2 | K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021 | — |
| +2 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| +2 | K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 15.3 · 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? (3)
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 |
|---|---|---|---|
| * | K940838 | Microvasive Ultraflex Esophageal Stent SystemSummary page 1…Third Party Reviewed: NO 3. Predicate Device: Microvasive Ultraflex Esophageal Stent System Boston Scientific Corporation k940838 Niti-S Stent & Introducer, Model Esophageal, Taewoong Medical Co., Ltd K041648 Cook Esophag… | 1994 |
| * | K041648 | Niti-S Stent & Introducer, Model EoxxxxSummary page 1…l Stent System Boston Scientific Corporation k940838 Niti-S Stent & Introducer, Model Esophageal, Taewoong Medical Co., Ltd K041648 Cook Esophageal Z Stent with DUA Anti-Reflux Wilson-Cook Medical K011591 4. Description:… | 2005 |
| * | K011591 | Esophageal Z-Stent with Dua Anti-Reflux ValveSummary page 1…ducer, Model Esophageal, Taewoong Medical Co., Ltd K041648 Cook Esophageal Z Stent with DUA Anti-Reflux Wilson-Cook Medical K011591 4. Description: The proposed Niti-S Esophageal Stent consists of an implantable metallic stent and a flex… | 2002 |
What descends from it? (15)
See all 155 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2019 | Class II | Z-1229-2020 | Error in labeling | Misprinted IFUs shipped with esophageal stents |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K113551 (Taewoong Medical Co., Ltd., 2012) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K940838.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080782 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080782: Niti-S Esophageal Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080782
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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