510(k) · Cleared

Cleared

Ultraflex Diamond

K962899510(k) TraditionalCleared May 20, 1997299-day reviewClass II21 CFR 876.5010

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

Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on May 20, 1997 as substantially equivalent to K925406 (Schneider Intl., Ltd., 1995) after a 299-day review. Its family tree reaches back 1 generation to 1995. 22 later devices descend from it.

Decided: May 20, 1997
Review: 299 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925406 (1995). 22 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
This deviceK962899 Ultraflex DiamondBoston Scientific Corp · 1997
Descendant · cites it directly · 21 of its ownK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
Descendant · 2 generations on · 15 of its ownK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
Descendant · 3 generations on · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
Descendant · 2 generations on · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
Descendant · 2 generations on · 5 of its ownK072094 ChoostentM.I.Tech Co., Ltd. · 2008

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2001high 3 (2021) · low 0 (2002)2026

Most influential descendants

Showing 5 of 22 · See all

K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Boston Scientific Corp · 2001 · cites it directly21descendants
K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008 · 2 generations on15descendants
K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation · 2009 · 3 generations on14descendants
K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · 2 generations on5descendants
K072094ChoostentM.I.Tech Co., Ltd. · 2008 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925406	Biliary Endoprostheses W/Unistep Delivery System	Schneider Intl., Ltd.	1995	—
0 (this device)	K962899	Ultraflex Diamond	Boston Scientific Corp	1997	—
+1	K012883	Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System…	Boston Scientific Corp	2001	46
+2	K073266	Wallflex Partially Covered Esophageal Stent System	Boston Scientific Corp	2008	—
+3	K091510	Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710…	Boston Scientific Corporation	2009	—
+2	K121048	Ultraflex Tracheobronchial Stent System- Sterile Uncovered	Boston Scientific Corp	2012	—
+2	K072094	Choostent	M.I.Tech Co., Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2008	2	0
2009	1	0
2010	2	0
2012	1	0
2013	1	0
2014	2	0
2018	2	0
2019	1	0
2020	1	0
2021	3	0
2023	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K962899, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FGE? 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 FGE device

#1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K925406	Biliary Endoprostheses W/Unistep Delivery System Summary page 3 …YSTEM AND SCHNEIDER WALLSTENT® ENDOSCOMC BILIARY ENDOPROSTHESIS Ukraflex Diamond Bifary Schneider Walistent® Stent System Endoscopic Biiary (This 510(K) Endoprosthesis (K925406) USE Indication Malignant Biliary Strictures «— Same Route of Administration Endoscopic «— Same STENT Overall OD 10 mm 8-12mm Ove…	Schneider Intl., Ltd.	1995	—

Also cleared against K925406: 2 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K012883	Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…	Boston Scientific Corp	2001	21

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?

Its one ancestor has no recall.
Of its descendants, K012883 (Boston Scientific Corp, 2001) has gone furthest, with 21 descendants of its own.
2 other devices also cite its predicate K925406.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

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

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, 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	4	316	54	1,006
2008	11	214	93	1,465
2009	7	160	18	1,655
2010	9	81	32	1,434
2011	9	114	2	1,321
2012	8	96	4	1,183
2013	5	161	3	1,060
2014	8	156	0	1,270
2015	8	79	0	1,543
2016	4	49	0	1,453
2017	9	59	1	1,515
2018	7	215	43	1,681
2019	2	—	13	1,896
2020	4	121	1	2,182
2021	1	—	27	2,297
2022	6	101	21	1,749
2023	6	199	19	1,615
2024	6	188	1	1,948
2025	7	257	0	1,923
2026	8	153	11	—

What is it indicated for?

The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

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/K962899 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962899: Ultraflex Diamond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962899

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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