510(k) · Cleared
ClearedBonastent Tracheal / Bronchial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endochoice, Inc. · JCT Prosthesis, Tracheal, Expandable
Cleared on Oct 17, 2014 as substantially equivalent to K062511 (Alveolus, Inc., 2007) and 2 other predicates after a 234-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.
- Decided
- Oct 17, 2014
- Review
- 234 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K923119 (1992). 55 ancestors in all, the oldest K894380 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 5 generations between
- 3 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 2 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 1 generation backK093003 Bonastent BiliaryEndochoice, Inc. · 2010
- This deviceK140472 Bonastent Tracheal / BronchialEndochoice, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK201342 HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 8 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 7 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 6 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 5 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 4 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 3 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 2 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 1 generation backK093003 Bonastent BiliaryEndochoice, Inc. · 2010
- This deviceK140472 Bonastent Tracheal / BronchialEndochoice, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −8 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −7 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −6 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −5 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −4 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −3 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −2 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| −1 | K093003 | Bonastent Biliary | Endochoice, Inc. | 2010 | — |
| 0 (this device) | K140472 | Bonastent Tracheal / Bronchial | Endochoice, Inc. | 2014 | — |
| +1 | K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 JCT? 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 JCT device
- #1 K230269 Ultraflex™ Tracheobronchial Stent Systemscore 8.1 · 9 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 |
|---|---|---|---|
| * | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XXSummary page 5…2 Classification Panel: General & Plastic Surgery 3. PREDICATE DEVICES Main Predicate: AERO Tracheobronchial Stent System by Alveolus, Inc; K062511. Reference devices: Bonastent™ Esophageal by EndoChoice Inc.; K092144. Bonastent™ Biliary by EndoCho… | 2007 |
| * | K092144 | Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Summary page 5…Main Predicate: AERO Tracheobronchial Stent System by Alveolus, Inc; K062511. Reference devices: Bonastent™ Esophageal by EndoChoice Inc.; K092144. Bonastent™ Biliary by EndoChoice Inc.; K093003. BONASTENT® Tracheal/Bronchial - Page 5… | 2010 |
| * | K093003 | Bonastent BiliarySummary page 5…stem by Alveolus, Inc; K062511. Reference devices: Bonastent™ Esophageal by EndoChoice Inc.; K092144. Bonastent™ Biliary by EndoChoice Inc.; K093003. BONASTENT® Tracheal/Bronchial - Page 5-2 4. DEVICE DESCRIPTION The… | 2010 |
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 |
|---|---|---|---|
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | 2020 | 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 22 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 13 of the 55 ancestors have a recall of any class.
- Of its descendants, K201342 (M.I.Tech Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062511.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JCT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JCT
234in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCT
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCT
50in 2025
MAUDE reports naming product code JCT, 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 | 2 | — | 0 | 150 |
| 2008 | 1 | — | 0 | 143 |
| 2009 | 1 | — | 0 | 163 |
| 2010 | 0 | — | 46 | 147 |
| 2011 | 0 | — | 2 | 95 |
| 2012 | 1 | — | 0 | 109 |
| 2013 | 0 | — | 0 | 238 |
| 2014 | 3 | 234 | 0 | 168 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 1 | — | 0 | 217 |
| 2017 | 0 | — | 0 | 109 |
| 2018 | 1 | — | 0 | 122 |
| 2019 | 0 | — | 0 | 106 |
| 2020 | 1 | — | 0 | 120 |
| 2021 | 2 | — | 0 | 106 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 1 | — | 0 | 110 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 0 | 50 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140472: Bonastent Tracheal / Bronchial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140472
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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