510(k) · Cleared
ClearedHilzo Esophageal Stents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thoracent, Inc. · ESW Prosthesis, Esophageal
Cleared on Jan 16, 2024 as substantially equivalent to K080782 (Taewoong Medical Co., Ltd., 2009) after a 449-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jan 16, 2024
- Review
- 449 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955347 (1996). 8 ancestors in all, the oldest K920218 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK955347 UltraflexBoston Scientific Corp · 1996
- 3 generations backK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
- 2 generations backK041648 Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005
- 1 generation backK080782 Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · Recalled
- This deviceK223266 Hilzo Esophageal StentsThoracent, Inc. · 2024
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 | K041648 | Niti-S Stent & Introducer, Model Eoxxxx | Taewoong Medical Co., Ltd. | 2005 | — |
| −1 | K080782 | Niti-S Esophageal Stent | Taewoong Medical Co., Ltd. | 2009 | 1 |
| 0 (this device) | K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K080782 | Niti-S Esophageal StentSummary page 5…eal Stent System, manufactured by Taewoong Medical Co., Prosthesis, Esophageal ESW 878.3610 2 General & Plastic Surgery Gastroenterology/Urology Ltd., cleared under K080782; Product Code: ESW Page 594 of 597 K223266 Page 1 of 4 K223266 HILZO Esophageal Stents - Section 5: 510(k) Sum… | 2009 |
| † | K123205 | Esophageal TTS Stent | 2013 |
| † | K092144 | Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare… | 2010 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K080782.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
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/K223266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223266: Hilzo Esophageal Stents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223266
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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