510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Hickman Plastic Subcutaneous Port

K873213510(k) TraditionalCleared Oct 27, 198774-day reviewClass II21 CFR 880.5965Recalls 3

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 Oct 27, 1987 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 3 times.

Decided
Oct 27, 1987
Review
74 days
Class
Class II
Product code
LJT
Recalls
3
Predicates
0

7 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2016: 1 descendant cleared2007: 1 descendant cleared2002: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK873213 Hickman Plastic Subcutaneous PortC.R. Bard, Inc. · 1987
  2. Descendant · cites it directly · 2 of its ownK022983 Bardport X-Port Isp PortC.R. Bard, Inc. · 2002 · Recalled
  3. Descendant · cites it directly · 1 of its ownK073423 Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc. · 2007 · Recalled
  4. Descendant · cites it directly · 1 of its ownK991897 Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK181446 Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019
  6. Descendant · cites it directly · 0 of its ownK153359 BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 22002: 12007: 12014: 12016: 12019: 1
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K022983Bardport X-Port Isp PortC.R. Bard, Inc. · 2002 · cites it directly2descendants
  • K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc. · 2007 · cites it directly1descendant
  • K991897Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999 · cites it directly1descendant
  • K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019 · 2 generations on0descendants
  • K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K873213Hickman Plastic Subcutaneous PortC.R. Bard, Inc.1987—
+1K022983Bardport X-Port Isp PortC.R. Bard, Inc.20021
+1K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.20073
+1K991897Catheter Innovations Implantable PortCatheter Innovations, Inc.19999
+2K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.2019—
+1K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200210
200710
201410
201610
201910
FIG. 1 — Lineage of K873213, 1987–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 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?

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

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K022983Bardport X-Port Isp PortC.R. Bard, Inc.20022
K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.20071
K991897Catheter Innovations Implantable PortCatheter Innovations, Inc.19991
K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.20160
K133335Powerport Implantable PortC.R. Bard, Inc.20140
K993860Catheter Innovations Implantable PortCatheter Innovations, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 1, 2019Class IIZ-1576-2020Component change controlFirm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019Class IIZ-1577-2020Component change controlFirm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Feb 16, 2012Not classifiedZ-1133-2012Labeling Change ControlThe end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port instead of a "Bard Port MRI Implanted Port" as correctly indicated on the main label of the kit.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022983 (C.R. Bard, Inc., 2002) has gone furthest, with 2 descendants of its own.

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

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)—
Cite this page

510(k) Report. “K873213: Hickman Plastic Subcutaneous Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873213

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026