510(k) · Cleared
ClearedUltraflex Esophageal NG Stent System
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 Dec 6, 2013 as substantially equivalent to K091816 (Boston Scientific Corporation, 2009) and 2 other predicates after a 338-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 6, 2013
- Review
- 338 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K003173 (2001). 22 ancestors in all, the oldest K894380 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 7 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 6 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- 5 generations backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- 4 generations backK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- 3 generations backK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- 2 generations backK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- 1 generation backK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- This deviceK130004 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013
- Descendant · cites it directly · 1 of its ownK233939 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −7 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −6 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| −5 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| −4 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| −3 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| −2 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| −1 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K130004 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2013 | — |
| +1 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024 | 22 |
| +2 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent… | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K091816 | Ultraflex Esophageal NG Stent SystemSummary page 1…cation: Class 11 3. Predicate Device: Trade Name: UltraflexTm Esophageal NO Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K09 1816. K 120983 Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product Code: ESW Cl… | 2009 |
| * | K120983 | Ultraflex Esophageal NG Stent SystemSummary page 1…ass 11 3. Predicate Device: Trade Name: UltraflexTm Esophageal NO Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K09 1816. K 120983 Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product Code: ESW Classificati… | 2012 |
| * | K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredSummary page 1…Classification: Class 11 Trade Name: UltraflexTM 'rracheobronchial Stent System Manulfacturer and Clearance Number: Boston Scientific Corporation, K 121048 Classification Name: Prosthesis, Tracheal, Expandable Regulation Number: 878.3720 Product Code: JCT C… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | 2024 | 1 |
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 4 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K233939 (Boston Scientific, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K091816.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Ultraflex Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.
Ultraflex Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130004: Ultraflex Esophageal NG 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/K130004
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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