510(k) · Cleared
Recalled · 2010Ultraflex 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 Jul 1, 2009 as substantially equivalent to K032930 (Boston Scientific Corp, 2003) after a 13-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 1, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- ESW
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955347 (1996). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK955347 UltraflexBoston Scientific Corp · 1996
- 1 generation backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
- This deviceK091816 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2009
- Descendant · cites it directly · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- Descendant · cites it directly · 3 of its ownK120983 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2012
- Descendant · cites it directly · 2 of its ownK130004 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK233939 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK141584 Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · cites it directly5descendants
- K120983Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2012 · cites it directly3descendants
- K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013 · cites it directly2descendants
- K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · 2 generations on1descendant
- K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955347 | Ultraflex | Boston Scientific Corp | 1996 | — |
| −1 | K032930 | Ultraflex Esophageal NG Stent System | Boston Scientific Corp | 2003 | 16 |
| 0 (this device) | K091816 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2009 | — |
| +1 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| +1 | K120983 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2012 | — |
| +1 | K130004 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2013 | — |
| +2 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024 | 22 |
| +2 | K141584 | Ultraflex Tracheobronchial Covered Stent System | Boston Scientific Corporation | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 15.3 · 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 |
|---|---|---|---|
| * | K032930 | Ultraflex Esophageal NG Stent SystemSummary page 1…ation: Class III 3. Predicate Device: Trade Name: UltraflexTM Esophageal NG Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K03 2930 Classification Name: Esophageal Prosthesis Regulation Number: 878.361 0 Product Code: ESW Classificat… | 2003 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2010 | Not classified | Z-2322-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2321-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2323-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2319-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2316-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2320-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2318-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Jul 15, 2010 | Not classified | Z-2324-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment |
| Jul 15, 2010 | Not classified | Z-2317-2010 | Process control | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K121048 (Boston Scientific Corp, 2012) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K032930.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
UltraflexTM 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.
UltraflexTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091816: Ultraflex Esophageal NG Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091816
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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