510(k) · Cleared
ClearedFlamingo Wallstent Esophageal Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schneider (Europe) GmbH · ESW Prosthesis, Esophageal
Cleared on Jan 7, 1999 as substantially equivalent to K940396 (Boston Scientific Scimed, Inc., 1994) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jan 7, 1999
- Review
- 52 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923119 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- This deviceK984068 Flamingo Wallstent Esophageal EndoprosthesisSchneider (Europe) GmbH · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| 0 (this device) | K984068 | Flamingo Wallstent Esophageal Endoprosthesis | Schneider (Europe) GmbH | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K940396 | Wallstent Esophageal Prosthesis (Double)Summary page 1…el. ++41 872 11 11; Telefax ++41 862 05 04 Contact: Thomas Thaler, Ph. D. Director, Clinical and Regulatory Affairs Predicate Device: WALLSTENT® Esophageal Prosthesis, K940396 and K923119 Device Description: The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of… | 1994 |
| * | K923119 | Wallstent Esophageal ProthesisSummary page 1…11 11; Telefax ++41 862 05 04 Contact: Thomas Thaler, Ph. D. Director, Clinical and Regulatory Affairs Predicate Device: WALLSTENT® Esophageal Prosthesis, K940396 and K923119 Device Description: The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of biomedical… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K940396.
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 | — |
What is it indicated for?
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the
- palliative treatment of strictures of the esophagus, including cardia, due to a malignant process
- palliative treatment of tracheo-esophageal fistulae due to a malignant process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984068: Flamingo Wallstent Esophageal Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984068
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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