510(k) · Cleared

Cleared

Eliminator Balloon Dilator

K940965510(k) TraditionalCleared May 20, 199479-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

C.R. Bard, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on May 20, 1994 as substantially equivalent to K863437 (C.R. Bard, Inc., 1986) after a 79-day review. Its family tree reaches back 1 generation to 1986. 44 later devices descend from it.

Decided: May 20, 1994
Review: 79 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K863437 (1986). 44 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK863437 Bard Balloon Dilatation SystemC.R. Bard, Inc. · 1986
This deviceK940965 Eliminator Balloon DilatorC.R. Bard, Inc. · 1994
Descendant · cites it directly · 42 of its ownK023765 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
Descendant · cites it directly · 42 of its ownK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
Descendant · 2 generations on · 41 of its ownK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
Descendant · 2 generations on · 39 of its ownK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
Descendant · 2 generations on · 38 of its ownK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2001high 5 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 44 · See all

K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002 · cites it directly42descendants
K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001 · cites it directly42descendants
K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on41descendants
K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp. · 2003 · 2 generations on39descendants
K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863437	Bard Balloon Dilatation System	C.R. Bard, Inc.	1986	—
0 (this device)	K940965	Eliminator Balloon Dilator	C.R. Bard, Inc.	1994	—
+1	K023765	Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	2002	—
+1	K013139	Stellartech Coagulation System	Stellartech Research Corp.	2001	—
+2	K032062	Stellartech Coagulation System, Models (1100C-115 & 1100C-230)	Stellartech Research Corp.	2003	—
+2	K032452	Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230	Stellartech Research Corp.	2003	—
+2	K032721	Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	3	0
2004	3	0
2005	1	0
2006	5	0
2007	1	0
2008	2	0
2009	3	0
2010	3	0
2012	2	0
2013	1	0
2014	2	0
2015	1	0
2016	2	0
2017	2	0
2018	2	0
2019	2	0
2020	1	0
2021	3	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K940965, 1986–2025Source: 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

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What was it cleared against? (2)

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
*	K863437	Bard Balloon Dilatation System Summary page 1 …tor, Quality Assurance and Regulatory Affairs Date of Summary: 1 March 1994 Name of Device: Bard® Balloon Dilator Predicate Devices: Bard® Balloon Dilatation System (K863437) Microvasive Achiever™ (Boston Scientific, Inc.) Description and Intended Use of Device: The Bard® Balloon Dilator is a 6Fr. po…	C.R. Bard, Inc.	1986	—
*	—	Microvasive Achiever™ Named without a submission number			—

Also cleared against K863437: 1 other device →

What descends from it? (44)

See all 44

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

Number	Device	Applicant	Decided	Descendants
K023765	Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	2002	42
K013139	Stellartech Coagulation System	Stellartech Research Corp.	2001	42

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, K023765 (Stellartech Research Corp., 2002) has gone furthest, with 42 descendants of its own.
1 other device also cites its predicate K863437.

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 Bard® Balloon Dilator is intended to be used for dilatation of strictures of the gastrointestinal tract, but not limited to strictures of the esophagus, pylorus, duodenum, sphincter of Oddi, biliary tree and colon.

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/K940965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940965: Eliminator Balloon Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940965

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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