510(k) · Decided
Recalled · 2010Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · ESW Prosthesis, Esophageal
Cleared on Oct 12, 2001 as substantially equivalent to K940838 (Boston Scientific Corp, 1994) and 2 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1995. 21 later devices descend from it. It has been recalled 46 times.
- Decided
- Oct 12, 2001
- Review
- 45 days
- Class
- Class II
- Product code
- ESW
- Recalls
- 46
- Predicates
- 3
Its longest line of descent runs back 2 generations to K925406 (1995). 4 ancestors in all, the oldest K940838 (1994). 21 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
- 1 generation backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
- This deviceK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001
- Descendant · cites it directly · 15 of its ownK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
- Descendant · 2 generations on · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
- Descendant · cites it directly · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- Descendant · cites it directly · 5 of its ownK072094 ChoostentM.I.Tech Co., Ltd. · 2008
- Descendant · 2 generations on · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
2008high 3 (2021) · low 0 (2011)2026
Most influential descendants
Showing 5 of 21 · See all- K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008 · cites it directly15descendants
- K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation · 2009 · 2 generations on14descendants
- K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · cites it directly5descendants
- K072094ChoostentM.I.Tech Co., Ltd. · 2008 · cites it directly5descendants
- K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925406 | Biliary Endoprostheses W/Unistep Delivery System | Schneider Intl., Ltd. | 1995 | — |
| −1 | K962899 | Ultraflex Diamond | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | — |
| +1 | K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corp | 2008 | — |
| +2 | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… | Boston Scientific Corporation | 2009 | — |
| +1 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| +1 | K072094 | Choostent | M.I.Tech Co., Ltd. | 2008 | — |
| +2 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 15.2 · 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? (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 6…ber: 878.3720 Prpduct Code: JCT Classification: Class I1 3. Predicate Device: Boston Scientific Corporation's UltraflexTMEsophageal Stent System, K940838 Boston Scientific Corporation's UltraflexTMDiamond Biliary Stent System, K962899 Boston Scientific Corporation's Ul… | 1994 |
| * | K962899 | Ultraflex DiamondSummary page 6…vice: Boston Scientific Corporation's UltraflexTMEsophageal Stent System, K940838 Boston Scientific Corporation's UltraflexTMDiamond Biliary Stent System, K962899 Boston Scientific Corporation's UltraflexTMTracheobronchial Stent System, K96324.1 Boston Scienafic 4.… | 1997 |
| * | K963241 | Ultraflex | 1996 |
What descends from it? (21)
See all 214 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 |
|---|---|---|---|---|
| Jul 15, 2010 | Not classified | Z-2327-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2326-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2325-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2328-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2330-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2329-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| May 17, 2010 | Not classified | Z-1828-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1843-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1837-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1817-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1848-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1839-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1823-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1836-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1829-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1835-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1821-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1844-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1822-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1830-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1842-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1850-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1833-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1855-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1825-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1849-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1846-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1838-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1847-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1853-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1827-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1852-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1820-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1834-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1819-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1840-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1831-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1845-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1856-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1818-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1854-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1841-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1832-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1826-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1824-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
| May 17, 2010 | Not classified | Z-1851-2010 | Device Design | Suture related device failures during deployment and repositioning of the stent |
The 5 latest of 46 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073266 (Boston Scientific Corp, 2008) has gone furthest, with 15 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.
FDA decisions per year · ESW
3in 2025
2007high 5 (2008) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · ESW
90in 2025
2007high 206 (2010) · low 35 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ESW
25in 2010
2007high 25 (2010) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESW
120in 2025
2007high 255 (2010) · low 77 (2021)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?
The Ultraflex Diamond Biliaty Stent is indicated for palliative treatment of patients with malignant biliaty strictures.
The Ultraflex Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
The ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012883
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026