510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Bardport Titanium Ports

K050310510(k) SpecialCleared Apr 18, 200569-day reviewClass II21 CFR 880.5965Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bard Access Systems, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Apr 18, 2005 as substantially equivalent to K870260 (C.R. Bard, Inc., 1987) after a 69-day review. Its family tree reaches back 1 generation to 1987. 68 later devices descend from it. It has been recalled 2 times.

Decided
Apr 18, 2005
Review
69 days
Class
Class II
Product code
LJT
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K870260 (1987). 68 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 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 cleared2013: 6 descendants cleared2012: 3 descendants cleared2016: 1 descendant cleared2017: 4 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants clearedK870260 · Hickman Titanium Subcutaneous Port · C.R. Bard, Inc. · 19871990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 19 descendants3 generations forward: 21 descendants4 generations forward: 13 descendants5 generations forward: 9 descendants6 generations forward: 3 descendants K870260 · Hickman Titanium Subcutaneous Port · C.R. Bard, Inc. · 19870+5
  1. Root · 1 generation backK870260 Hickman Titanium Subcutaneous PortC.R. Bard, Inc. · 1987
  2. This deviceK050310 Bardport Titanium PortsBard Access Systems, Inc. · 2005
  3. Descendant · cites it directly · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
  5. Descendant · 2 generations on · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
  7. Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2006: 12007: 122008: 72009: 22010: 22011: 52012: 32013: 62014: 32015: 22016: 12017: 42019: 22020: 22021: 32023: 32024: 22025: 62026: 2
2006high 12 (2007) · low 0 (2018)2026

Most influential descendants

Showing 5 of 68 · See all
  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · cites it directly66descendants
  • K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp · 2007 · 2 generations on20descendants
  • K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · 2 generations on20descendants
  • K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · 2 generations on18descendants
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K870260Hickman Titanium Subcutaneous PortC.R. Bard, Inc.1987—
0 (this device)K050310Bardport Titanium PortsBard Access Systems, Inc.2005—
+1K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
+2K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp20073
+2K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
+2K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…Smiths Medical MD, Inc.2007—
+2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
2007120
200870
200920
201020
201150
201230
201360
201430
201520
201610
201740
201920
202020
202130
202330
202420
202560
202620
FIG. 1 — Lineage of K050310, 1987–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K870260Hickman Titanium Subcutaneous Port
Summary page 1
…21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion Podt and Catheter, Class 1I Premarket Notification: K870260, concurrence date - April 15, 1987 6.4 Device Description Principle of Operation There are no new operating…
C.R. Bard, Inc.1987—

Also cleared against K870260: 2 other devices →

What descends from it? (68)

See all 68

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

NumberDeviceApplicantDecidedDescendants
K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.200666
K133335Powerport Implantable PortC.R. Bard, Inc.20140
K070911STD Med Primo PortStd Med, Inc.20070

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 1, 2019Class IIZ-1575-2020Component 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.
Aug 30, 2011Not classifiedZ-3173-2011Labeling Change ControlImplanted port has discrepant product information on package labeling.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K060812 (C.R. Bard, Inc., 2006) has gone furthest, with 66 descendants of its own.
  • 2 other devices also cite its predicate K870260.

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)—

What is it indicated for?

The BardPort® 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 K870260

2 other devices cite the same predicate.

  • K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016
  • K122834Polysite Implantable Infusion PortsPerouse Medical · 2013

More from Bard Access Systems, Inc.

21 FDA decisions under this applicant name. See the company

  • 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
  • K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc. · 2024
  • K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc. · 2024
  • K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc. · 2024

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/K050310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050310: Bardport Titanium Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050310

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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