510(k) Report

510(k) · Cleared

Recalled · 2010

Trimport Implantable Access System (Modification)

K954258510(k) TraditionalCleared May 24, 1996262-day reviewClass II21 CFR 880.5965Recalls 12

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

Gerard Medical Enterprises, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on May 24, 1996 after a 262-day review. The FDA summary names its predicate without a number. It has been recalled 12 times.

Decided
May 24, 1996
Review
262 days
Class
Class II
Product code
LJT
Recalls
12
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K954258Source: FDA 510(k) database · 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
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What was it cleared against? (2)

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
*—Ideas' Port
Named without a submission number
—
*—LifePort with PolyCath Catheter
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 13, 2010Not classifiedZ-1883-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010Not classifiedZ-1882-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010Not classifiedZ-1886-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010Not classifiedZ-1881-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010Not classifiedZ-1887-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010Not classifiedZ-1884-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010Not classifiedZ-1885-2010Nonconforming Material/ComponentFDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
Jun 13, 2006Not classifiedZ-0745-2007OtherMispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error)
Jun 13, 2006Not classifiedZ-0746-2007OtherMispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)
Oct 28, 2005Not classifiedZ-0340-06OtherDevice kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Jul 22, 2005Not classifiedZ-1481-05OtherThe Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Jul 22, 2005Not classifiedZ-1476-05OtherThe Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

The 5 latest of 12 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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 Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Gerard Medical Enterprises, Inc.

8 FDA decisions under this applicant name. See the company

  • K945250TrimportGerard Medical Enterprises, Inc. · 19957 recalls
  • K942623TrimportGerard Medical Enterprises, Inc. · 19947 recalls
  • K922147Dual Plastic Vascular Access SystemGerard Medical Enterprises, Inc. · 1992
  • K913114Trim-Port (TM) Implant Access Syst Dual Titan PortGerard Medical Enterprises, Inc. · 1992
  • K912111Modified Version Implantable Vascular Access SysteGerard Medical Enterprises, Inc. · 1991

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/K954258 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954258: Trimport Implantable Access System (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954258

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026