510(k) Report

510(k) · Cleared

Recalled · 2009

Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports

K081472510(k) TraditionalCleared Sep 23, 2008119-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

AngioDynamics, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Sep 23, 2008 as substantially equivalent to K072375 (AngioDynamics, Inc., 2007) and 5 other predicates after a 119-day review. Its family tree reaches back 9 generations to 2000. 4 later devices descend from it. It has been recalled once.

Decided
Sep 23, 2008
Review
119 days
Class
Class II
Product code
LJT
Recalls
1
Predicates
6

Its longest line of descent runs back 9 generations to K001901 (2000). 34 ancestors in all, the oldest K863606 (1986). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 3 other ancestors2001: 3 other ancestors1996: 1 other ancestor1991: 2 other ancestors2002: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2005: 2 other ancestors2000: 2 other ancestors1992: 1 other ancestor2004: 2 other ancestors1989: 4 other ancestors1987: 1 other ancestor1986: 1 other ancestor2011: 3 descendants cleared2020: 1 descendant clearedK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalledK062414 · Vortex CT Port Access System and Lifeguard Safety Infusion Set · Rita Medical Systems, Inc. · 2007 · recalledK072375 · Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set · AngioDynamics, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 5 other ancestors4 generations back: 8 other ancestors5 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K072375 · Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set · AngioDynamics, Inc. · 2007K062414 · Vortex CT Port Access System and Lifeguard Safety Infusion Set · Rita Medical Systems, Inc. · 2007 · recalledK060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalledK051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 5 generations between
  3. 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  4. 2 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  5. 1 generation backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
  6. This deviceK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008
  7. Descendant · cites it directly · 3 of its ownK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
  8. Descendant · cites it directly · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  9. Descendant · 2 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
  10. Descendant · 3 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Show all 9 generations
  1. Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. 2 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  9. 1 generation backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
  10. This deviceK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008

Most influential descendants

Showing 4 of 4 · See all
  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011 · cites it directly3descendants
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · cites it directly2descendants
  • K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 2 generations on1descendant
  • K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−8K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−7K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−6K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−5K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−4K051672PowerpiccBard Access Systems, Inc.20051
−3K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
−2K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
−1K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.2007—
0 (this device)K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low…AngioDynamics, Inc.2008—
+1K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.2011—
+1K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical2011—
+2K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.2011—
+3K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198940
199120
199210
199410
199510
199610
200020
200130
200210
200330
200420
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201130
202010
FIG. 1 — Lineage of K081472, 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? (6)

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
*K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set
Summary page 1
…ct Code: UT Regulatory Class: II Legally marketed device to which equivalence is claimed: AngioDynamics SmartPort CT MP 510(k) K072375 AngioDynamics SmartPort CT 5 10(k) K062414 Horizon Medical Vortex Ports 5 10(k) K905841, K953529, KO10 189, K03…
AngioDynamics, Inc.2007—
*K062414Vortex CT Port Access System and Lifeguard Safety Infusion Set
Summary page 1
…II Legally marketed device to which equivalence is claimed: AngioDynamics SmartPort CT MP 510(k) K072375 AngioDynamics SmartPort CT 5 10(k) K062414 Horizon Medical Vortex Ports 5 10(k) K905841, K953529, KO10 189, K032557 Intended Use / Indications The SmartPort CT Po…
Rita Medical Systems, Inc.20072
*K905841Strato Port Introducer KT (12 FR) LPS 5200/Modified
Summary page 1
…alence is claimed: AngioDynamics SmartPort CT MP 510(k) K072375 AngioDynamics SmartPort CT 5 10(k) K062414 Horizon Medical Vortex Ports 5 10(k) K905841, K953529, KO10 189, K032557 Intended Use / Indications The SmartPort CT Port Access System is indicated for any adult patient r…
Strato Medical Corp.1991—
*K953529Strato/Infusaid Life & Infuse-a-Port Implantable Port System
Summary page 1
…claimed: AngioDynamics SmartPort CT MP 510(k) K072375 AngioDynamics SmartPort CT 5 10(k) K062414 Horizon Medical Vortex Ports 5 10(k) K905841, K953529, KO10 189, K032557 Intended Use / Indications The SmartPort CT Port Access System is indicated for any adult patient requiring…
Strato/Infusaid, Inc.19961
*K010189Vortex Access SystemHorizon Medical Products, Inc.20012
*K032557Triumph VTX with Lifevalve Catheter
Summary page 1
…amics SmartPort CT MP 510(k) K072375 AngioDynamics SmartPort CT 5 10(k) K062414 Horizon Medical Vortex Ports 5 10(k) K905841, K953529, KO10 189, K032557 Intended Use / Indications The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of…
Horizon Medical Products, Inc.20031

Also cleared against K072375: 1 other device →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113
K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 16, 2009Not classifiedZ-1898-2009Packaging process controlThe product may contain an incorrect size catheter and introducer.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 20 of the 34 ancestors have a recall of any class.
  • Of its descendants, K102385 (Norfolk Medical Products, Inc., 2011) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K072375.

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. 2008, this device’s year, is highlighted.

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 SmartPort CT Series Port Access System is indicated for any patient requiring

repeated access of the vascular system for the delivery of medications, nutritional

supplementation, fluids, blood, blood products, and the sampling of blood.

The SmartPort CT Series Port Access System is also indicated for power injection of

contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20

Ga or 19 Ga power injectable infusion sets.

Indications for use as stated in the FDA summary.

Also cleared against K072375

1 other device cites the same predicate.

  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011

More from AngioDynamics, Inc.

87 FDA decisions under this applicant name. See the company

  • K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc. · 2025
  • K253106AngioVac CannulaAngioDynamics, Inc. · 2025
  • K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090)…AngioDynamics, Inc. · 2024
  • K240397AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc. · 2024
  • K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsAngioDynamics, Inc. · 2023

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/K081472 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081472

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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