510(k) · Cleared

Cleared

Bard Balloon Dilatation System

K863437510(k) TraditionalCleared Oct 29, 198654-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 Oct 29, 1986 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided: Oct 29, 1986
Review: 54 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 0

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

This deviceK863437 Bard Balloon Dilatation SystemC.R. Bard, Inc. · 1986
Descendant · cites it directly · 44 of its ownK940965 Eliminator Balloon DilatorC.R. Bard, Inc. · 1994
Descendant · 2 generations on · 42 of its ownK023765 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
Descendant · 2 generations on · 42 of its ownK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
Descendant · 3 generations on · 41 of its ownK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
Descendant · 3 generations on · 39 of its ownK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

1994high 5 (2006) · low 0 (1995)2026

Most influential descendants

Showing 5 of 47 · See all

K940965Eliminator Balloon DilatorC.R. Bard, Inc. · 1994 · cites it directly44descendants
K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002 · 2 generations on42descendants
K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001 · 2 generations on42descendants
K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 3 generations on41descendants
K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp. · 2003 · 3 generations on39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K863437	Bard Balloon Dilatation System	C.R. Bard, Inc.	1986	—
+1	K940965	Eliminator Balloon Dilator	C.R. Bard, Inc.	1994	—
+2	K023765	Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	2002	—
+2	K013139	Stellartech Coagulation System	Stellartech Research Corp.	2001	—
+3	K032062	Stellartech Coagulation System, Models (1100C-115 & 1100C-230)	Stellartech Research Corp.	2003	—
+3	K032452	Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230	Stellartech Research Corp.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1999	1	0
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	2	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 K863437, 1986–2025Source: 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 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?

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

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K940965	Eliminator Balloon Dilator	C.R. Bard, Inc.	1994	44
K983220	Stryker Infravision Esophageal Kit	Stryker Endoscopy	1999	1

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, K940965 (C.R. Bard, Inc., 1994) has gone furthest, with 44 descendants of its own.

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	—

https://510kreport.com/device/K863437 · printed Nov 5, 2026

Cite this page

510(k) Report. “K863437: Bard Balloon Dilatation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K863437

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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