510(k) · Cleared

Cleared

Vas-Cath Permanent Dual Lumen Hemodialysis Cath

K871488510(k) TraditionalCleared Jun 12, 198758-day reviewClass II21 CFR 876.5540

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

Vas-Cath of Canada, Ltd. · LFJ Catheter, Subclavian

Cleared on Jun 12, 1987 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.

Decided: Jun 12, 1987
Review: 58 days
Class: Class II
Product code: LFJ
Recalls: None
Predicates: 0

8 later devices descend from it, 2 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.

This deviceK871488 Vas-Cath Permanent Dual Lumen Hemodialysis CathVas-Cath of Canada, Ltd. · 1987
Descendant · cites it directly · 6 of its ownK965178 Niagara Dual Lumen CatheterVas-Cath, Inc. · 1997
Descendant · 2 generations on · 2 of its ownK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
Descendant · 2 generations on · 1 of its ownK090102 Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension…C.R. Bard, Inc. · 2009 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
Descendant · 3 generations on · 0 of its ownK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997high 2 (2002) · low 0 (1998)2026

Class I recalls in this family

K030268 Niagara Temporary Dual Lumen Catheters…2 generations on · 2003
K090102 Niagara, Niagara Slim-Cath, and Brevia…2 generations on · 2009

Most influential descendants

Showing 5 of 8 · See all

K965178Niagara Dual Lumen CatheterVas-Cath, Inc. · 1997 · cites it directly6descendants
K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002 · 2 generations on2descendants
K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc. · 2009 · 2 generations on1descendant
K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011 · 3 generations on0descendants
K022688Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K871488	Vas-Cath Permanent Dual Lumen Hemodialysis Cath	Vas-Cath of Canada, Ltd.	1987	—
+1	K965178	Niagara Dual Lumen Catheter	Vas-Cath, Inc.	1997	—
+2	K012193	Amc Antimicrobial Pin/Wire Sleeve	Smith & Nephew, Inc.	2002	—
+2	K090102	Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension…	C.R. Bard, Inc.	2009	Class I
+3	K102833	Disposable Hemodialysis Access Catheter Sets	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	2011	—
+3	K022688	Versabond AB Bone Cement	Smith & Nephew, Inc.	2004	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	2	0
2003	2	1
2004	1	0
2009	1	1
2011	1	0

FIG. 1 — Lineage of K871488, 1987–2011Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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? (8)

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

Number	Device	Applicant	Decided	Descendants
K965178	Niagara Dual Lumen Catheter	Vas-Cath, Inc.	1997	6
K030277	Soft-Cell Dual Lumen Catheters	C.R. Bard, Inc.	2003	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K030268Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersC.R. Bard, Inc. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K965178 (Vas-Cath, Inc., 1997) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LFJ devices

LFJ Catheter, Subclavian: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFJ

FDA has decided no LFJ device since 2007.

Median 510(k) review, days · LFJ

Too few LFJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LFJ

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LFJ

28in 2025

2007high 48 (2024) · low 22 (2008)2025

MAUDE reports naming product code LFJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	27
2008	—	0	22
2009	—	0	26
2010	—	0	45
2011	—	0	23
2012	—	0	34
2013	—	0	29
2014	—	0	23
2015	—	0	26
2016	—	0	34
2017	—	0	31
2018	—	0	31
2019	—	0	45
2020	—	0	43
2021	—	0	37
2022	—	0	34
2023	—	0	44
2024	—	0	48
2025	—	0	28
2026	—	1 (1)	—

https://510kreport.com/device/K871488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K871488: Vas-Cath Permanent Dual Lumen Hemodialysis Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871488

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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