510(k) Report

510(k) · Cleared

Recalled · 2010

Lifeport VTX Access System,Model VTX 7000 Series

K010767510(k) SpecialCleared Apr 10, 200127-day reviewClass II21 CFR 880.5965Recalls 1

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 Apr 10, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it. It has been recalled once.

Decided
Apr 10, 2001
Review
27 days
Class
Class II
Product code
LJT
Recalls
1
Predicates
0

22 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2005: 1 descendant cleared2008: 2 descendants cleared2011: 3 descendants cleared2016: 1 descendant cleared2009: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK010767 Lifeport VTX Access System,Model VTX 7000 SeriesHorizon Medical Products, Inc. · 2001
  2. Descendant · cites it directly · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
  5. Descendant · 2 generations on · 5 of its ownK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
  6. Descendant · 2 generations on · 4 of its ownK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005: 12007: 22008: 22009: 12011: 32014: 12016: 12017: 22020: 12021: 32023: 12024: 12025: 22026: 1
2005high 3 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all
  • K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · cites it directly20descendants
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
  • K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 3 generations on6descendants
  • K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc. · 2007 · 2 generations on5descendants
  • K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc. · 2008 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010767Lifeport VTX Access System,Model VTX 7000 SeriesHorizon Medical Products, Inc.2001—
+1K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
+2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
+3K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…B.Braun Medical, Inc.2017—
+2K072375Smartport 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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200720
200820
200910
201130
201410
201610
201720
202010
202130
202310
202410
202520
202610
FIG. 1 — Lineage of K010767, 2001–2026Source: 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), 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? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.200720
K050176Vortex EZ Vascular Access PortRita Medical Systems, Inc.20050

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 27, 2010Not classifiedZ-0404-2011OtherLabeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062414 (Rita Medical Systems, Inc., 2007) has gone furthest, with 20 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)—

More from Horizon Medical Products, Inc.

16 FDA decisions under this applicant name. See the company

  • K033473Modification to Vortex MP Vascular Access PortHorizon Medical Products, Inc. · 20032 recalls
  • 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

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/K010767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010767: Lifeport VTX Access System,Model VTX 7000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010767

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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