510(k) · Cleared
ClearedPolyflex Stent System with Delivery System, Model M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · ESW Prosthesis, Esophageal
Cleared on Sep 5, 2008 as substantially equivalent to K030559 (Rusch Intl., 2003) after a 211-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Sep 5, 2008
- Review
- 211 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030559 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030559 Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemRusch Intl. · 2003
- This deviceK080332 Polyflex Stent System with Delivery System, Model M00514270…Boston Scientific Corporation · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030559 | Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System | Rusch Intl. | 2003 | — |
| 0 (this device) | K080332 | Polyflex Stent System with Delivery System, Model M00514270, M00514280… | Boston Scientific Corporation | 2008 | — |
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 15.3 · 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 |
|---|---|---|---|
| * | K030559 | Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemSummary page 1…al Regulation Number: 878.3610 Product Code: ESW Classification: Class II 3. Predicate Devices Polyflex Esophageal Single-Use Stent System, K030559 4. Device Description The Polyflex Esophageal Stent System consists of a stent and delivery system. The stent is composed of a… | 2003 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K030559.
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?
Stenting:
Esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures (resectable and non-resectable)
Stenting esophago-respiratory fistulas
Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080332 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080332: Polyflex Stent System with Delivery System, Model M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080332
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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