510(k) Report

510(k) · Cleared

Cleared

Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and Befr

K092144510(k) TraditionalCleared Feb 22, 2010222-day reviewClass II21 CFR 878.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endochoice, Inc. · ESW Prosthesis, Esophageal

Cleared on Feb 22, 2010 as substantially equivalent to K012883 (Boston Scientific Corp, 2001) and 5 other predicates after a 222-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.

Decided
Feb 22, 2010
Review
222 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K925406 (1995). 23 ancestors in all, the oldest K920218 (1994). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2005: 2 other ancestors2004: 1 other ancestor2003: 3 other ancestors2002: 1 other ancestor2001: 1 other ancestor1996: 2 other ancestors1994: 3 other ancestors2000: 2 other ancestors2014: 1 descendant cleared2020: 1 descendant clearedK925406 · Biliary Endoprostheses W/Unistep Delivery System · Schneider Intl., Ltd. · 1995K962899 · Ultraflex Diamond · Boston Scientific Corp · 1997K012883 · Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System · Boston Scientific Corp · 2001 · recalledK073266 · Wallflex Partially Covered Esophageal Stent System · Boston Scientific Corp · 2008K091510 · Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 · Boston Scientific Corporation · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K091510 · Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 · Boston Scientific Corporation · 2009K073266 · Wallflex Partially Covered Esophageal Stent System · Boston Scientific Corp · 2008K012883 · Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System · Boston Scientific Corp · 2001 · recalledK962899 · Ultraflex Diamond · Boston Scientific Corp · 1997K925406 · Biliary Endoprostheses W/Unistep Delivery System · Schneider Intl., Ltd. · 1995−50
  1. Root · 5 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
  2. 4 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
  3. 3 generations backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
  4. 2 generations backK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
  5. 1 generation backK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
  6. This deviceK092144 Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S.…Endochoice, Inc. · 2010
  7. Descendant · cites it directly · 1 of its ownK140472 Bonastent Tracheal / BronchialEndochoice, Inc. · 2014
  8. Descendant · 2 generations on · 0 of its ownK201342 HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K140472Bonastent Tracheal / BronchialEndochoice, Inc. · 2014 · cites it directly1descendant
  • K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K925406Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd.1995—
−4K962899Ultraflex DiamondBoston Scientific Corp1997—
−3K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System…Boston Scientific Corp200146
−2K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp2008—
−1K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710…Boston Scientific Corporation2009—
0 (this device)K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange…Endochoice, Inc.2010—
+1K140472Bonastent Tracheal / BronchialEndochoice, Inc.2014—
+2K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199430
199620
200020
200110
200210
200330
200410
200520
200820
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
202010
FIG. 1 — Lineage of K092144, 1995–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…
Summary page 1
…Class II Review Panel: Gastroenterology/Urology Predicate Devices: * UltrafleXTM1 Esophageal Sternt System by Boston Scientific Corporation, K012883. * Wallfiex Partially Covered Esophageal Stent System by Boston Scientific Corporation, K073266, K(091510. *…
Boston Scientific Corp200146
*K073266Wallflex Partially Covered Esophageal Stent System
Summary page 1
…Sternt System by Boston Scientific Corporation, K012883. * Wallfiex Partially Covered Esophageal Stent System by Boston Scientific Corporation, K073266, K(091510. * Choostent TM covered Esophageal Stent by M.IL Tech Co., Ltd., K072094. * Nlti-S Esophageal St…
Boston Scientific Corp2008—
*K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…
Summary page 1
…tem by Boston Scientific Corporation, K012883. * Wallfiex Partially Covered Esophageal Stent System by Boston Scientific Corporation, K073266, K(091510. * Choostent TM covered Esophageal Stent by M.IL Tech Co., Ltd., K072094. * Nlti-S Esophageal Stent by Tae…
Boston Scientific Corporation2009—
*K072094Choostent
Summary page 1
…red Esophageal Stent System by Boston Scientific Corporation, K073266, K(091510. * Choostent TM covered Esophageal Stent by M.IL Tech Co., Ltd., K072094. * Nlti-S Esophageal Stent by Taewoong Medical Co., Ltd., K080782, K041648) Device Description: The BonastentT…
M.I.Tech Co., Ltd.2008—
*K080782Niti-S Esophageal Stent
Summary page 1
…73266, K(091510. * Choostent TM covered Esophageal Stent by M.IL Tech Co., Ltd., K072094. * Nlti-S Esophageal Stent by Taewoong Medical Co., Ltd., K080782, K041648) Device Description: The BonastentTm Esophageal Stent is a covered, self-expanding tubular prosthesis desi…
Taewoong Medical Co., Ltd.20091
*K041648Niti-S Stent & Introducer, Model Eoxxxx
Summary page 1
…* Choostent TM covered Esophageal Stent by M.IL Tech Co., Ltd., K072094. * Nlti-S Esophageal Stent by Taewoong Medical Co., Ltd., K080782, K041648) Device Description: The BonastentTm Esophageal Stent is a covered, self-expanding tubular prosthesis designed to maintain p…
Taewoong Medical Co., Ltd.2005—

Also cleared against K012883: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141

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 15 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 6 of the 23 ancestors have a recall of any class.
  • Of its descendants, K140472 (Endochoice, Inc., 2014) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K012883.

How does its category compare?

All ESW devices

ESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · ESW

3in 2025

2008: 52009: 32010: 32011: 12012: 22013: 22016: 12018: 22019: 12020: 12021: 42022: 12024: 42025: 32026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ESW

90in 2025

2008: 99 days median2009: 35 days median2010: 206 days median2021: 139 days median2024: 130 days median2025: 90 days median
2007high 206 (2010) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ESW

25in 2010

2010: 25
2007high 25 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ESW

120in 2025

2007: 882008: 1532009: 2392010: 2552011: 1402012: 1212013: 1452014: 1692015: 1752016: 1532017: 872018: 862019: 1672020: 1552021: 772022: 1092023: 1552024: 1662025: 120
2007high 255 (2010) · low 77 (2021)2025

MAUDE reports naming product code ESW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—088
20085990153
20093350239
2010320625255
20111—0140
20122—0121
20132—0145
20140—0169
20150—0175
20161—0153
20170—087
20182—086
20191—0167
20201—0155
20214139077
20221—0109
20230—0155
202441300166
20253900120
20261—0—

What is it indicated for?

The BONASTENT™ Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.

Indications for use as stated in the FDA summary.

Also cleared against K012883

3 other devices cite the same predicate.

  • K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
  • K072094ChoostentM.I.Tech Co., Ltd. · 2008
  • K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008

More from Endochoice, Inc.

27 FDA decisions under this applicant name. See the company

  • K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. · 2016
  • K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc. · 2016
  • K161167Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016
  • K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. · 2016
  • K153588EndoChoice Water Bottle Cap SystemEndochoice, Inc. · 2016

Recent decisions in ESW

The ESW category page

  • K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026
  • K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd. · 2025
  • K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd. · 2025
  • K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc. · 2025
  • K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 202422 recalls

https://510kreport.com/device/K092144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092144: Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and Befr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092144

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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