510(k) · Cleared

Cleared

Hickman TriFusion Catheter

K172511510(k) TraditionalCleared Apr 20, 2018242-day reviewClass II21 CFR 880.5970

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. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Apr 20, 2018 as substantially equivalent to K041088 (C.R. Bard, Inc., 2004) after a 242-day review. Its family tree reaches back 2 generations to 1983.

Decided: Apr 20, 2018
Review: 242 days
Class: Class II
Product code: LJS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K830233 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK830233 Non-Sterile,Single/Souble Lumen-CathEvermed, Inc. · 1983 · Recalled
1 generation backK041088 Trifusion, Model 0609190/0659350C.R. Bard, Inc. · 2004
This deviceK172511 Hickman TriFusion CatheterC.R. Bard, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K830233	Non-Sterile,Single/Souble Lumen-Cath	Evermed, Inc.	1983	3
−1	K041088	Trifusion, Model 0609190/0659350	C.R. Bard, Inc.	2004	—
0 (this device)	K172511	Hickman TriFusion Catheter	C.R. Bard, Inc.	2018	—

FIG. 1 — Lineage of K172511, 1983–2018Source: 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 LJS? 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 LJS device

#1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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? (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
*	K041088	Trifusion, Model 0609190/0659350 Summary page 4 …Product Code: LJS Predicate Device: Hickman® TriFusion™ Catheter Common or Usual Name: Long-Term Intravascular Catheter Premarket Notification: K041088 Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 days Regu…	C.R. Bard, Inc.	2004	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 35 years and passes through 2 companies; a new generation was cleared every 21.7 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LJS

8in 2025

2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007high 284 (2021) · low 31 (2013)2026

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

Recalls per year · LJS

5in 2023

2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007high 4,372 (2025) · low 369 (2008)2025

MAUDE reports naming product code LJS, 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	14	92	0	392
2008	4	97	1	369
2009	16	70	1	379
2010	9	114	12	495
2011	6	55	4	696
2012	14	77	40	564
2013	14	31	0	680
2014	8	47	15	842
2015	7	71	2	1,306
2016	9	128	18	1,123
2017	7	101	9	2,100
2018	10	148	3	2,324
2019	0	—	0	2,052
2020	2	—	0	2,539
2021	3	284	1	3,084
2022	3	177	0	3,256
2023	4	47	5 (2)	2,799
2024	1	—	0	4,243
2025	8	171	0	4,372
2026	2	—	8 (1)	—

What is it indicated for?

The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular vein, and subclavian vein. All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of 1.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.

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/K172511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172511: Hickman TriFusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172511

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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