510(k) · Cleared

Cleared

Ultraflex

K955347510(k) TraditionalCleared Feb 16, 199687-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

Boston Scientific Corp · ESW Prosthesis, Esophageal

Cleared on Feb 16, 1996 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided: Feb 16, 1996
Review: 87 days
Class: Class II
Product code: ESW
Recalls: None
Predicates: 0

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

This deviceK955347 UltraflexBoston Scientific Corp · 1996
Descendant · cites it directly · 65 of its ownK032930 Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · Recalled
Descendant · 2 generations on · 27 of its ownK041648 Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005
Descendant · 3 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
Descendant · 2 generations on · 19 of its ownK051621 Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005
Descendant · 3 generations on · 17 of its ownK080838 Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2003high 6 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 66 · See all

K032930Ultraflex Esophageal NG Stent SystemBoston Scientific Corp · 2003 · cites it directly65descendants
K041648Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005 · 2 generations on27descendants
K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 3 generations on23descendants
K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005 · 2 generations on19descendants
K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008 · 3 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K955347	Ultraflex	Boston Scientific Corp	1996	—
+1	K032930	Ultraflex Esophageal NG Stent System	Boston Scientific Corp	2003	16
+2	K041648	Niti-S Stent & Introducer, Model Eoxxxx	Taewoong Medical Co., Ltd.	2005	—
+3	K073667	Niti-S Biliary Stent	Taewoong Medical Co., Ltd.	2008	—
+2	K051621	Endoventions Alimaxx-E Esophageal Stent System	Alveolus, Inc.	2005	—
+3	K080838	Alveolus Alimaxx-E Esophageal Stent System	Alveolus, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	3	0
2006	3	0
2008	4	0
2009	4	0
2010	4	0
2011	4	0
2012	6	0
2013	2	0
2014	4	0
2015	1	0
2016	1	0
2018	2	0
2019	1	0
2020	2	0
2021	5	0
2022	2	0
2023	5	0
2024	6	0
2025	5	0
2026	1	0

FIG. 1 — Lineage of K955347, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K032930	Ultraflex Esophageal NG Stent System	Boston Scientific Corp	2003	65
K073266	Wallflex Partially Covered Esophageal Stent System	Boston Scientific Corp	2008	15

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, K032930 (Boston Scientific Corp, 2003) has gone furthest, with 65 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

2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ESW

90in 2025

2007high 206 (2010) · low 35 (2009)2026

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

Recalls per year · ESW

25in 2010

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

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

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	—

https://510kreport.com/device/K955347 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955347: Ultraflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955347

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Record history

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