510(k) Report

510(k) · Cleared

Cleared

Hickman Titanium Subcutaneous Port

K870260510(k) TraditionalCleared Apr 15, 198782-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 Apr 15, 1987 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 70 later devices descend from it.

Decided
Apr 15, 1987
Review
82 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
0

70 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2013: 6 descendants cleared2005: 1 descendant cleared2007: 12 descendants cleared2006: 1 descendant cleared2014: 3 descendants cleared2019: 2 descendants cleared2008: 7 descendants cleared2009: 2 descendants cleared2011: 5 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2023: 3 descendants cleared2024: 2 descendants cleared2012: 3 descendants cleared2017: 4 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK870260 Hickman Titanium Subcutaneous PortC.R. Bard, Inc. · 1987
  2. Descendant · cites it directly · 68 of its ownK050310 Bardport Titanium PortsBard Access Systems, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
  5. Descendant · 3 generations on · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  6. Descendant · 3 generations on · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 122008: 72009: 22010: 22011: 52012: 32013: 62014: 32015: 22016: 22017: 42019: 22020: 22021: 32023: 32024: 22025: 62026: 2
2005high 12 (2007) · low 0 (2018)2026

Most influential descendants

Showing 5 of 70 · See all
  • K050310Bardport Titanium PortsBard Access Systems, Inc. · 2005 · cites it directly68descendants
  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 2 generations on66descendants
  • K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp · 2007 · 3 generations on20descendants
  • K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · 3 generations on20descendants
  • K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · 3 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870260Hickman Titanium Subcutaneous PortC.R. Bard, Inc.1987—
+1K050310Bardport Titanium PortsBard Access Systems, Inc.20052
+2K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
+3K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp20073
+3K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
+3K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…Smiths Medical MD, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
2007120
200870
200920
201020
201150
201230
201360
201430
201520
201620
201740
201920
202020
202130
202330
202420
202560
202620
FIG. 1 — Lineage of K870260, 1987–2026Source: 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
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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? (70)

See all 70

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

NumberDeviceApplicantDecidedDescendants
K050310Bardport Titanium PortsBard Access Systems, Inc.200568
K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.20160
K122834Polysite Implantable Infusion PortsPerouse Medical20130

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?

  • Of its descendants, K050310 (Bard Access Systems, Inc., 2005) has gone furthest, with 68 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)—

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711 FDA decisions under this applicant name. See the company

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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/K870260 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870260: Hickman Titanium Subcutaneous Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870260

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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