510(k) · Cleared
ClearedEndomaxx Fully Covered Esophageal Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · ESW Prosthesis, Esophageal
Cleared on Jul 29, 2011 as substantially equivalent to K051621 (Alveolus, Inc., 2005) and 1 other predicate after a 50-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jul 29, 2011
- Review
- 50 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K955347 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955347 UltraflexBoston Scientific Corp · 1996
- 3 generations backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
- 2 generations backK051621 Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005
- 1 generation backK080838 Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008
- This deviceK111611 Endomaxx Fully Covered Esophageal StentMerit Medical Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK251265 Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955347 | Ultraflex | Boston Scientific Corp | 1996 | — |
| −3 | K032930 | Ultraflex Esophageal NG Stent System | Boston Scientific Corp | 2003 | 16 |
| −2 | K051621 | Endoventions Alimaxx-E Esophageal Stent System | Alveolus, Inc. | 2005 | — |
| −1 | K080838 | Alveolus Alimaxx-E Esophageal Stent System | Alveolus, Inc. | 2008 | — |
| 0 (this device) | K111611 | Endomaxx Fully Covered Esophageal Stent | Merit Medical Systems, Inc. | 2011 | — |
| +1 | K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025 | — |
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 |
|---|---|---|
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051621 | Endoventions Alimaxx-E Esophageal Stent SystemSummary page 1…is, Esophageal Predicate Device Trade Name: ALIMAXX-ESTM Esophageal Stern Classification Name: Prosthesis, Esophageal Premarket Notification: K05 1621 & K080838 Classification CER Listing: Class 11 per 21 CFR 878.3610 Product Code: ESW Review Branch:… | 2005 |
| * | K080838 | Alveolus Alimaxx-E Esophageal Stent SystemSummary page 1…eal Predicate Device Trade Name: ALIMAXX-ESTM Esophageal Stern Classification Name: Prosthesis, Esophageal Premarket Notification: K05 1621 & K080838 Classification CER Listing: Class 11 per 21 CFR 878.3610 Product Code: ESW Review Branch:… | 2008 |
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 |
|---|---|---|---|
| K251265 | Resilience Fully Covered Esophageal Stent System | 2025 | 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 15 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K251265 (Merit Medical Systems, Inc., 2025) has gone furthest, with 0 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. 2011, 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 MERIT ENDOTEKTM EndoMAXXTm Fully Covered Esophageal Stent is intended for maintaining esophageal luminal 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/K111611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111611: Endomaxx Fully Covered Esophageal Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111611
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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