510(k) · Decided
DecidedNiti-S Biliary Stent; Niti-S Biliary Slim M Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taewoong Medical Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Dec 29, 2025 as substantially equivalent to K221071 (Taewoong Medical Co., Ltd., 2022) and 1 other predicate after a 262-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Dec 29, 2025
- Review
- 262 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K923119 (1992). 27 ancestors in all, the oldest K911292 (1991). No later device cites it as a predicate yet.
- Root · 11 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 7 generations between
- 3 generations backK111149 Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011
- 2 generations backK202973 HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd. · 2021
- 1 generation backK221071 Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2022
- This deviceK251123 Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 10 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 9 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 8 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 7 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 6 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 5 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 4 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 3 generations backK111149 Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011
- 2 generations backK202973 HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd. · 2021
- 1 generation backK221071 Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2022
- This deviceK251123 Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −10 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −9 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −8 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −7 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −6 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −5 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −4 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| −3 | K111149 | Hanarostent Biliary (NNN) | M.I.Tech Co., Ltd. | 2011 | — |
| −2 | K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | 2021 | — |
| −1 | K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2022 | — |
| 0 (this device) | K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 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? (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 |
|---|---|---|---|
| * | K221071 | Niti-S Biliary Slim M StentSummary page 5…TE DEVICE INFORMATION Primary Predicate Device Name: Niti-S Biliary Slim M Stent 510(k) Number: K221071 Manufacturer: Taewoong Medical Co., Ltd.… | 2022 |
| * | K073667 | Niti-S Biliary StentSummary page 6…Taewoong Medical Secondary Predicate Device Name: Niti-S Biliary Stent 510(k) Number: K073667 Manufacturer: Taewoong Medical Co., Ltd. Reference Device Name:… | 2008 |
| † | K240522 | Esophageal TTS Stent | 2024 |
| † | K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | 2025 |
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 33 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 27 ancestors have a recall of any class.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251123 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251123: Niti-S Biliary Stent; Niti-S Biliary Slim M Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251123
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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