510(k) · Decided
DecidedHanarostent Biliary (NNN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.I.Tech Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Dec 30, 2011 as substantially equivalent to K073667 (Taewoong Medical Co., Ltd., 2008) after a 249-day review. Its family tree reaches back 8 generations to 1992. 6 later devices descend from it.
- Decided
- Dec 30, 2011
- Review
- 249 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K923119 (1992). 24 ancestors in all, the oldest K911292 (1991). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 7 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 6 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 5 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 4 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 3 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 2 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 1 generation backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- This deviceK111149 Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK202973 HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK223354 EGIS Biliary Single Bare StentS&G Biotech, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK221071 Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK251123 Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242845 EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd. · 2021 · cites it directly2descendants
- K223354EGIS Biliary Single Bare StentS&G Biotech, Inc. · 2023 · cites it directly1descendant
- K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2022 · 2 generations on1descendant
- K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. · 2025 · 3 generations on0descendants
- K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −7 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −6 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −5 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −4 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −3 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −2 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −1 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| 0 (this device) | K111149 | Hanarostent Biliary (NNN) | M.I.Tech Co., Ltd. | 2011 | — |
| +1 | K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | 2021 | — |
| +1 | K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | 2023 | — |
| +2 | K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2022 | — |
| +3 | K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025 | — |
| +2 | K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K073667 | Niti-S Biliary StentSummary page 1…the Food, Drug and Cosmetic Act. 3. Predicate Device(s): Niti-S Biliary Stent & Introducer, K073667 4. Description of Device: The HANAROSTENT" Biliary (NNN) is a self-expanding uncoated tubular prosthesis… | 2008 |
What descends from it? (6)
3 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 19 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 24 ancestors have a recall of any class.
- Of its descendants, K202973 (M.I.Tech Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K073667.
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. 2011, 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 HANAROSTENT® BILIARY (NNN) 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/K111149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111149: Hanarostent Biliary (NNN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111149
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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