510(k) · Cleared
ClearedMicrovasive Ultraflex Esophageal 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 Aug 18, 1994 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Aug 18, 1994
- Review
- 176 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 3 citing it directly.
- This deviceK940838 Microvasive Ultraflex Esophageal Stent SystemBoston Scientific Corp · 1994
- Descendant · cites it directly · 21 of its ownK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- Descendant · cites it directly · 15 of its ownK080782 Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · Recalled
- 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 · 2 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Boston Scientific Corp · 2001 · cites it directly21descendants
- K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · cites it directly15descendants
- 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
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940838 | Microvasive Ultraflex Esophageal Stent System | Boston Scientific Corp | 1994 | — |
| +1 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| +1 | K080782 | Niti-S Esophageal Stent | Taewoong Medical Co., Ltd. | 2009 | 1 |
| +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 | — |
| +2 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 313 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?
- Of its descendants, K012883 (Boston Scientific Corp, 2001) has gone furthest, with 21 descendants of its own.
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
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 | — |
https://510kreport.com/device/K940838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940838: Microvasive Ultraflex Esophageal 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/K940838
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026