510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Modification to Vortex MP Vascular Access Port

K033473510(k) SpecialCleared Nov 18, 200315-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

Horizon Medical Products, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Nov 18, 2003 as substantially equivalent to K032754 (Horizon Medical Products, Inc., 2003) after a 15-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it. It has been recalled 2 times.

Decided
Nov 18, 2003
Review
15 days
Class
Class II
Product code
LJT
Recalls
2
Predicates
1

Its longest line of descent runs back 2 generations to K994196 (2000). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2011: 3 descendants cleared2008: 1 descendant cleared2020: 1 descendant clearedK994196 · Horizon Medical Products Microport 2 Peripheral Access Port System · Horizon Medical Products, Inc. · 2000K032754 · Vortex MP · Horizon Medical Products, Inc. · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K032754 · Vortex MP · Horizon Medical Products, Inc. · 2003 · recalledK994196 · Horizon Medical Products Microport 2 Peripheral Access Port System · Horizon Medical Products, Inc. · 20000
  1. Root · 2 generations backK994196 Horizon Medical Products Microport 2 Peripheral Access Port SystemHorizon Medical Products, Inc. · 2000
  2. 1 generation backK032754 Vortex MPHorizon Medical Products, Inc. · 2003 · Recalled
  3. This deviceK033473 Modification to Vortex MP Vascular Access PortHorizon Medical Products, Inc. · 2003
  4. Descendant · cites it directly · 5 of its ownK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
  5. Descendant · 2 generations on · 4 of its ownK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
  6. Descendant · 3 generations on · 3 of its ownK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
  7. Descendant · 2 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  8. Descendant · 3 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12011: 32020: 1
2007high 3 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc. · 2007 · cites it directly5descendants
  • K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc. · 2008 · 2 generations on4descendants
  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011 · 3 generations on3descendants
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · 2 generations on2descendants
  • K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K994196Horizon Medical Products Microport 2 Peripheral Access Port SystemHorizon Medical Products, Inc.2000—
−1K032754Vortex MPHorizon Medical Products, Inc.20031
0 (this device)K033473Modification to Vortex MP Vascular Access PortHorizon Medical Products, Inc.2003—
+1K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.2007—
+2K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low…AngioDynamics, Inc.20081
+3K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.2011—
+2K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical2011—
+3K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201130
202010
FIG. 1 — Lineage of K033473, 2000–2020Source: 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
*K032754Vortex MPHorizon Medical Products, Inc.20031

Also cleared against K032754: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.20075

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 20, 2022Class IIZ-0132-2023Under Investigation by firmPrinted Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port…
Aug 30, 2010Not classifiedZ-3071-2011Labeling False and MisleadingThe labeling contains errors which result in the products being misbranded

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K072375 (AngioDynamics, Inc., 2007) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K032754.

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 Vortex MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Indications for use as stated in the FDA summary.

Also cleared against K032754

1 other device cites the same predicate.

  • K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc. · 2007

More from Horizon Medical Products, Inc.

16 FDA decisions under this applicant name. See the company

  • K032754Vortex MPHorizon Medical Products, Inc. · 20031 recall
  • K032557Triumph VTX with Lifevalve CatheterHorizon Medical Products, Inc. · 20031 recall
  • K031718Lifevalve Central Venous CathterHorizon Medical Products, Inc. · 2003
  • K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc. · 2002
  • K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 20023 recalls

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/K033473 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033473: Modification to Vortex MP Vascular Access Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033473

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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