510(k) · Cleared

Cleared

Modification to X-Port Duo Port

K034065510(k) SpecialCleared Jan 15, 200417-day reviewClass II21 CFR 880.5965

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. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Jan 15, 2004 as substantially equivalent to K032044 (C.R. Bard, Inc., 2003) after a 17-day review. Its family tree reaches back 2 generations to 1991.

Decided: Jan 15, 2004
Review: 17 days
Class: Class II
Product code: LJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K912702 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK912702 Plastic Attachable Dual PortDavol, Inc. · 1991
1 generation backK032044 X-Prot Duo PortC.R. Bard, Inc. · 2003
This deviceK034065 Modification to X-Port Duo PortC.R. Bard, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K912702	Plastic Attachable Dual Port	Davol, Inc.	1991	—
−1	K032044	X-Prot Duo Port	C.R. Bard, Inc.	2003	—
0 (this device)	K034065	Modification to X-Port Duo Port	C.R. Bard, Inc.	2004	—

FIG. 1 — Lineage of K034065, 1991–2004Source: 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 LJT? 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 LJT device

#1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 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
*	K032044	X-Prot Duo Port Summary page 1 …21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion Port and Catheter, Class II Premarket Notification: K032044, concurrence date - 10 July 2003. 6.4 Device Description Principles of Operation There are no new operating p…	C.R. Bard, Inc.	2003	—

Also cleared against K032044: 1 other device →

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 13 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K032044.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJT

2in 2025

2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007high 182 (2016) · low 85 (2007)2026

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

Recalls per year · LJT

1in 2022

2007high 19 (2010) · low 0 (2013)2026

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

Adverse event reports per year · LJT

4,308in 2025

2007high 4,308 (2025) · low 135 (2016)2025

MAUDE reports naming product code LJT, 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	11	85	1	208
2008	7	119	2	161
2009	2	—	2	172
2010	2	—	19	207
2011	5	144	1	202
2012	2	—	2	153
2013	7	150	0	141
2014	2	—	0	143
2015	4	164	1	149
2016	3	182	0	135
2017	0	—	1	262
2018	0	—	1	878
2019	1	—	7	765
2020	1	—	0	959
2021	0	—	0	1,285
2022	0	—	1	1,334
2023	1	—	0	1,221
2024	1	—	0	1,896
2025	2	—	0	4,308
2026	1	—	1 (1)	—

What is it indicated for?

The BardPort®, SlimPortTM and X-PortTM Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K034065 · printed Nov 4, 2026

Cite this page

510(k) Report. “K034065: Modification to X-Port Duo Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034065

Report an extraction error

Are you the manufacturer?

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