510(k) Report

510(k) · Cleared

Cleared

Wallstent Esophageal Prothesis

K923119510(k) TraditionalCleared Sep 1, 199267-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

Schneider U.S. Stent Div. · ESW Prosthesis, Esophageal

Cleared on Sep 1, 1992 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it.

Decided
Sep 1, 1992
Review
67 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
0

49 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 3 descendants cleared1995: 1 descendant cleared1996: 3 descendants cleared1998: 2 descendants cleared2001: 1 descendant cleared2006: 1 descendant cleared2016: 1 descendant cleared2013: 2 descendants cleared2003: 1 descendant cleared2008: 2 descendants cleared2009: 3 descendants cleared2011: 2 descendants cleared2012: 2 descendants cleared2002: 1 descendant cleared2010: 1 descendant cleared2022: 2 descendants cleared2025: 3 descendants cleared2023: 3 descendants cleared2014: 3 descendants cleared2021: 3 descendants cleared2019: 1 descendant cleared2024: 4 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
  2. Descendant · cites it directly · 47 of its ownK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
  3. Descendant · 2 generations on · 45 of its ownK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
  4. Descendant · 2 generations on · 44 of its ownK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
  5. Descendant · 3 generations on · 41 of its ownK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
  6. Descendant · 3 generations on · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

1995: 11996: 31998: 21999: 32001: 12002: 12003: 12006: 12008: 22009: 32010: 12011: 22012: 22013: 22014: 32016: 12018: 12019: 12020: 22021: 32022: 22023: 32024: 42025: 32026: 1
1995high 4 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 49 · See all
  • K945494Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · cites it directly47descendants
  • K961296Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · 2 generations on45descendants
  • K964121Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · 2 generations on44descendants
  • K980163Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis…Boston Scientific Scimed, Inc. · 1998 · 3 generations on41descendants
  • K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · 3 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923119Wallstent Esophageal ProthesisSchneider U.S. Stent Div.1992—
+1K945494Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc.19951
+2K961296Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc.19961
+2K964121Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc.19961
+3K980163Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial…Boston Scientific Scimed, Inc.19981
+3K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
199630
199820
199930
200110
200210
200310
200610
200820
200930
201010
201120
201220
201320
201430
201610
201810
201910
202020
202130
202220
202330
202440
202530
202610
FIG. 1 — Lineage of K923119, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (49)

See all 49

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K945494Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc.199547
K984068Flamingo Wallstent Esophageal EndoprosthesisSchneider (Europe) GmbH19990

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?

  • Of its descendants, K945494 (Boston Scientific Scimed, Inc., 1995) has gone furthest, with 47 descendants of its own.

How does its category compare?

All ESW devices

ESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Schneider U.S. Stent Div.

3 FDA decisions under this applicant name. See the company

  • K923993Wallstent Biliary EndoprothesesSchneider U.S. Stent Div. · 1994
  • K914277Wallstent (R) Trans Biliary Endo W/Unistep Deliv SYSchneider U.S. Stent Div. · 1991

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/K923119 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923119: Wallstent Esophageal Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923119

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026