510(k) Report

510(k) · Cleared

Cleared

BardPort®, SlimPort®, and X-Port® Implanted Ports

K153359510(k) SpecialCleared May 20, 2016182-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 May 20, 2016 as substantially equivalent to K022983 (C.R. Bard, Inc., 2002) and 4 other predicates after a 182-day review. Its family tree reaches back 2 generations to 1987.

Decided
May 20, 2016
Review
182 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K873213 (1987). 5 ancestors in all, the oldest K870260 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestorReference device: K081311 · Powerport Implanted Port with Groshong Catheter · C.R. Bard, Inc. · 2008K873213 · Hickman Plastic Subcutaneous Port · C.R. Bard, Inc. · 1987 · recalledK022983 · Bardport X-Port Isp Port · C.R. Bard, Inc. · 2002 · recalled1985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors K022983 · Bardport X-Port Isp Port · C.R. Bard, Inc. · 2002 · recalledK873213 · Hickman Plastic Subcutaneous Port · C.R. Bard, Inc. · 1987 · recalled0
  1. Root · 2 generations backK873213 Hickman Plastic Subcutaneous PortC.R. Bard, Inc. · 1987 · Recalled
  2. 1 generation backK022983 Bardport X-Port Isp PortC.R. Bard, Inc. · 2002 · Recalled
  3. This deviceK153359 BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K873213Hickman Plastic Subcutaneous PortC.R. Bard, Inc.19873
−1K022983Bardport X-Port Isp PortC.R. Bard, Inc.20021
0 (this device)K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198810
199310
FIG. 1 — Lineage of K153359, 1987–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K022983Bardport X-Port Isp Port
Summary page 4
…e: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Premarket Notification: K022983: BardPort® X-Port® isp Port Manufacturer: Bard Access Systems, Inc. Cur…
C.R. Bard, Inc.20021
*K924250Plastic Low Profile Subcutaneous Port
Summary page 4
…e: Subcutaneous, Implanted, Intravascular Infusion Port Predicate and Catheter Devices Premarket Notification: K924250: Plastic Low Profile Subcutaneous Port Manufacturer: Bard Access Systems, Inc.…
Bard Access Systems, Inc.1993—
*K880571Cath-Tech Port Implantable Vascular Access System
Summary page 4
…on Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Premarket Notification: K880571: Cath-Tech Port Implantable Vascular Access System Manufactur…
Catheter Technology Corp.1988—
*K873213Hickman Plastic Subcutaneous Port
Summary page 5
…e: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Premarket Notification: K873213: Hickman Plastic Subcutaneous Port Manufacturer: Bard Access Systems, Inc. Predicate…
C.R. Bard, Inc.19873
*K870260Hickman Titanium Subcutaneous Port
Summary page 5
…e: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Premarket Notification: K870260: Hickman Titanium Subcutaneous Port Manufacturer: Bard Access Systems, Inc.…
C.R. Bard, Inc.1987—
†K081311Powerport Implanted Port with Groshong CatheterC.R. Bard, Inc.2008—

Also cleared against K022983: 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 29 years and passes through 1 company; a new generation was cleared every 14.9 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 1 other device also cites its predicate K022983.

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. 2016, this device’s year, is highlighted.

FDA decisions per year · LJT

2in 2025

2007: 112008: 72009: 22010: 22011: 52012: 22013: 72014: 22015: 42016: 32019: 12020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007: 85 days median2008: 119 days median2011: 144 days median2013: 150 days median2015: 164 days median2016: 182 days median
2007high 182 (2016) · low 85 (2007)2026

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

Recalls per year · LJT

1in 2022

2007: 12008: 22009: 22010: 192011: 12012: 22015: 12017: 12018: 12019: 72022: 12026 (partial year): 1, 1 Class I
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

2007: 2082008: 1612009: 1722010: 2072011: 2022012: 1532013: 1412014: 1432015: 1492016: 1352017: 2622018: 8782019: 7652020: 9592021: 1,2852022: 1,3342023: 1,2212024: 1,8962025: 4,308
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711851208
200871192161
20092—2172
20102—19207
201151441202
20122—2153
201371500141
20142—0143
201541641149
201631820135
20170—1262
20180—1878
20191—7765
20201—0959
20210—01,285
20220—11,334
20231—01,221
20241—01,896
20252—04,308
20261—1 (1)—

What is it indicated for?

The BardPort®, SlimPort®, and X-Port® 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.

Also cleared against K022983

1 other device cites the same predicate.

  • K133335Powerport Implantable PortC.R. Bard, Inc. · 2014

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in LJT

The LJT category page

  • K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
  • K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port…Bard Access Systems, Inc. · 2025
  • K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port…Bard Access Systems, Inc. · 2025
  • K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc. · 2024
  • K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable…Bard Peripheral Vascular, Inc. · 2023

https://510kreport.com/device/K153359 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153359: BardPort®, SlimPort®, and X-Port® Implanted Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153359

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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