510(k) Report

510(k) · Cleared

Cleared

Endoventions Alimaxx-E Esophageal Stent System

K051621510(k) TraditionalCleared Jul 11, 200521-day reviewClass II21 CFR 878.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alveolus, Inc. · ESW Prosthesis, Esophageal

Cleared on Jul 11, 2005 as substantially equivalent to K032930 (Boston Scientific Corp, 2003) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1996. 19 later devices descend from it.

Decided
Jul 11, 2005
Review
21 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K955347 (1996). 3 ancestors in all. 19 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2006: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2018: 2 descendants cleared2010: 1 descendant cleared2024: 2 descendants cleared2014: 2 descendants cleared2021: 3 descendants cleared2025: 2 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared2020: 1 descendant clearedK955347 · Ultraflex · Boston Scientific Corp · 1996K032930 · Ultraflex Esophageal NG Stent System · Boston Scientific Corp · 2003 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants K032930 · Ultraflex Esophageal NG Stent System · Boston Scientific Corp · 2003 · recalledK955347 · Ultraflex · Boston Scientific Corp · 19960
  1. Root · 2 generations backK955347 UltraflexBoston Scientific Corp · 1996
  2. 1 generation backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
  3. This deviceK051621 Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005
  4. Descendant · cites it directly · 17 of its ownK080838 Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008
  5. Descendant · cites it directly · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
  6. Descendant · 2 generations on · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
  7. Descendant · 2 generations on · 3 of its ownK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
  8. Descendant · 2 generations on · 2 of its ownK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 12010: 12011: 12014: 22018: 22020: 12021: 32023: 12024: 22025: 22026: 1
2006high 3 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 19 · See all
  • K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008 · cites it directly17descendants
  • K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation · 2009 · cites it directly14descendants
  • K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · 2 generations on3descendants
  • K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018 · 2 generations on3descendants
  • K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K955347UltraflexBoston Scientific Corp1996—
−1K032930Ultraflex Esophageal NG Stent SystemBoston Scientific Corp200316
0 (this device)K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc.2005—
+1K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc.2008—
+1K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710…Boston Scientific Corporation2009—
+2K180144Agile Esophageal Stent SystemBoston Scientific Corporation2018—
+2K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2018—
+2K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200910
201010
201110
201420
201820
202010
202130
202310
202420
202520
202610
FIG. 1 — Lineage of K051621, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032930Ultraflex Esophageal NG Stent System
Summary page 1
…21 CFR 878.3610 - Class II Predicate Devices Boston Scientific Corp. Inc. Ultraflex TM Esophageal NG Stent System [501 (k) Number K032930] Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559]…
Boston Scientific Corp200316
*K030559Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System
Summary page 1
…geal NG Stent System [501 (k) Number K032930] Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559] Description The Endoventions Esophageal Stent Technology System is comprised of two components: the stent…
Rusch Intl.2003—

Also cleared against K032930: 6 other devices →

What descends from it? (19)

See all 19

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc.200817
K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914
K111611Endomaxx Fully Covered Esophageal StentMerit Medical Systems, Inc.20111
K060239Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent SystemAlveolus, Inc.20060

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 9 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K080838 (Alveolus, Inc., 2008) has gone furthest, with 17 descendants of its own.
  • 6 other devices also cite its predicate K032930.

How does its category compare?

All ESW devices

ESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ESW

3in 2025

2008: 52009: 32010: 32011: 12012: 22013: 22016: 12018: 22019: 12020: 12021: 42022: 12024: 42025: 32026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ESW

90in 2025

2008: 99 days median2009: 35 days median2010: 206 days median2021: 139 days median2024: 130 days median2025: 90 days median
2007high 206 (2010) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ESW

25in 2010

2010: 25
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

2007: 882008: 1532009: 2392010: 2552011: 1402012: 1212013: 1452014: 1692015: 1752016: 1532017: 872018: 862019: 1672020: 1552021: 772022: 1092023: 1552024: 1662025: 120
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—088
20085990153
20093350239
2010320625255
20111—0140
20122—0121
20132—0145
20140—0169
20150—0175
20161—0153
20170—087
20182—086
20191—0167
20201—0155
20214139077
20221—0109
20230—0155
202441300166
20253900120
20261—0—

What is it indicated for?

The Endoventions ALIMAXX-E Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.

Indications for use as stated in the FDA summary.

Also cleared against K032930

6 other devices cite the same predicate.

  • K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd. · 2010
  • K091816Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 20099 recalls
  • K080359Evolution Esophageal Stent SystemCook Ireland, Ltd. · 2008
  • K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
  • K043260Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
  • K041648Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005

More from Alveolus, Inc.

12 FDA decisions under this applicant name. See the company

  • K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
  • K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
  • K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008
  • K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 20086 recalls
  • K071604Alveolus Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2007

Recent decisions in ESW

The ESW category page

  • K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026
  • K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd. · 2025
  • K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd. · 2025
  • K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc. · 2025
  • K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 202422 recalls

https://510kreport.com/device/K051621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051621: Endoventions 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/K051621

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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