510(k) Report

510(k) · Cleared

Cleared

Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set

K072375510(k) TraditionalCleared Dec 13, 2007112-day reviewClass II21 CFR 880.5440

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

AngioDynamics, Inc. · FPA Set, Administration, Intravascular

Cleared on Dec 13, 2007 as substantially equivalent to K060812 (C.R. Bard, Inc., 2006) and 3 other predicates after a 112-day review. Its family tree reaches back 8 generations to 2000. 5 later devices descend from it.

Decided
Dec 13, 2007
Review
112 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K001901 (2000). 27 ancestors in all, the oldest K863606 (1986). 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2005: 2 other ancestors2002: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestors2004: 2 other ancestors1992: 1 other ancestor1987: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestors1986: 1 other ancestor2011: 3 descendants cleared2008: 1 descendant 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors4 generations back: 7 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K062414 · 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 · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 4 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 3 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 2 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. 1 generation backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  9. This deviceK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
  10. Descendant · cites it directly · 4 of its ownK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
  11. Descendant · 2 generations on · 3 of its ownK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
  12. Descendant · cites it directly · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  13. Descendant · 2 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
  14. Descendant · 3 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020

Most influential descendants

Showing 5 of 5 · See all
  • K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc. · 2008 · cites it directly4descendants
  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011 · 2 generations on3descendants
  • 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
−8K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−7K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−6K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−5K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−4K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−3K051672PowerpiccBard Access Systems, Inc.20051
−2K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
−1K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
0 (this device)K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.2007—
+1K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low…AngioDynamics, Inc.20081
+2K102385Norfolk 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
199110
199210
200020
200120
200210
200320
200420
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201130
202010
FIG. 1 — Lineage of K072375, 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 FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (4)

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
*K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple
Summary page 2
…l Hospital Product Code: FPA Regulatory Class: lI Legally marketed device to which equivalence is claimed: C.R. Bard PowerPort, 5 10(k) K060812 Angiodynamics Smartport CT and LifeGuard Needle, 510(k) K062414 Vortex MP Vascular Access Port, 5 10(k) K033473, K032754 Intende…
C.R. Bard, Inc.20061
*K062414Vortex CT Port Access System and Lifeguard Safety Infusion Set
Summary page 2
…lI Legally marketed device to which equivalence is claimed: C.R. Bard PowerPort, 5 10(k) K060812 Angiodynamics Smartport CT and LifeGuard Needle, 510(k) K062414 Vortex MP Vascular Access Port, 5 10(k) K033473, K032754 Intended Use / Indications The Smartport CT MPPort Access System is ind…
Rita Medical Systems, Inc.20072
*K033473Modification to Vortex MP Vascular Access Port
Summary page 2
…ich equivalence is claimed: C.R. Bard PowerPort, 5 10(k) K060812 Angiodynamics Smartport CT and LifeGuard Needle, 510(k) K062414 Vortex MP Vascular Access Port, 5 10(k) K033473, K032754 Intended Use / Indications The Smartport CT MPPort Access System is indicated for any adult patient requiring repeated…
Horizon Medical Products, Inc.20032
*K032754Vortex MP
Summary page 2
…alence is claimed: C.R. Bard PowerPort, 5 10(k) K060812 Angiodynamics Smartport CT and LifeGuard Needle, 510(k) K062414 Vortex MP Vascular Access Port, 5 10(k) K033473, K032754 Intended Use / Indications The Smartport CT MPPort Access System is indicated for any adult patient requiring repeated access of…
Horizon Medical Products, Inc.20031

Also cleared against K060812: 18 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.20084
K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • 16 of the 27 ancestors have a recall of any class.
  • Of its descendants, K081472 (AngioDynamics, Inc., 2008) has gone furthest, with 4 descendants of its own.
  • 18 other devices also cite its predicate K060812.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The LifeGuard® CT Safety Infusion Set is indicated for use in the access of implanted vascular ports for the administration of fluids and drugs, as well as blood sampling.

The 20ga and 19ga LifeGuard® CT Safety Infusion Sets are also indicated for power injection of contrast media when used with Smartport CT power injectable port access systems.

Indications for use as stated in the FDA summary.

Also cleared against K060812

18 other devices cite the same predicate.

  • K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc. · 2025
  • K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019
  • K110407InvisiportStealth Therapeutics, Incorporated · 2011
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
  • K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc. · 20101 recall

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 FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K072375 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072375

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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