510(k) · Cleared
ClearedAlveolus Alimaxx-E Esophageal Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alveolus, Inc. · ESW Prosthesis, Esophageal
Cleared on Apr 24, 2008 as substantially equivalent to K051621 (Alveolus, Inc., 2005) after a 30-day review. Its family tree reaches back 3 generations to 1996. 17 later devices descend from it.
- Decided
- Apr 24, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955347 (1996). 4 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK955347 UltraflexBoston Scientific Corp · 1996
- 2 generations backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
- 1 generation backK051621 Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005
- This deviceK080838 Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
- Descendant · cites it directly · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- Descendant · 2 generations on · 3 of its ownK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- Descendant · 3 generations on · 2 of its ownK201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation · 2009 · cites it directly14descendants
- K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · cites it directly3descendants
- K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018 · 2 generations on3descendants
- K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021 · 2 generations on2descendants
- K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955347 | Ultraflex | Boston Scientific Corp | 1996 | — |
| −2 | K032930 | Ultraflex Esophageal NG Stent System | Boston Scientific Corp | 2003 | 16 |
| −1 | K051621 | Endoventions Alimaxx-E Esophageal Stent System | Alveolus, Inc. | 2005 | — |
| 0 (this device) | K080838 | Alveolus Alimaxx-E Esophageal Stent System | Alveolus, Inc. | 2008 | — |
| +1 | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… | Boston Scientific Corporation | 2009 | — |
| +1 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| +2 | K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +2 | K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021 | — |
| +3 | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K051621 | Endoventions Alimaxx-E Esophageal Stent SystemSummary page 1…esis", Product code: ESW 21 CFR 878.3610 - Class II Predicate Device Alveolus ALIMAXX-E TM Esophageal Stent System [510(k) Number K051621] Description The Alveolus ALIMAXX-ETM Esophageal Stent System is designed to maintain lumen patency in esoph… | 2005 |
What descends from it? (17)
See all 173 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 12 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K091510 (Boston Scientific Corporation, 2009) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K051621.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Alveolus ALIMAXX-ETM Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors and for occlusion of esophageal fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080838: Alveolus Alimaxx-E 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/K080838
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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