510(k) Report

510(k) · Cleared

Cleared

Bard Power-Injectable Implantable Ports (PowerPorts®)

K181446510(k) TraditionalCleared Jul 8, 2019402-day reviewClass II21 CFR 880.5965

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

C.R. Bard, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Jul 8, 2019 as substantially equivalent to K060812 (C.R. Bard, Inc., 2006) and 7 other predicates after a 402-day review. Its family tree reaches back 9 generations to 2000.

Decided
Jul 8, 2019
Review
402 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K001901 (2000). 28 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2007: 2 other ancestors2005: 2 other ancestors1987: 2 other ancestors2004: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestorsK001901 · 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 · recalledK063377 · Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter · C.R. Bard, Inc. · 2007 · recalledK072215 · Titanium Powerport Isp Implanted Port · C.R. Bard, Inc. · 200719851990199520002005201020152020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors K072215 · Titanium Powerport Isp Implanted Port · C.R. Bard, Inc. · 2007K063377 · Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter · C.R. Bard, 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 backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
  5. 1 generation backK072215 Titanium Powerport Isp Implanted PortC.R. Bard, Inc. · 2007
  6. This deviceK181446 Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019
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 backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
  9. 1 generation backK072215 Titanium Powerport Isp Implanted PortC.R. Bard, Inc. · 2007
  10. This deviceK181446 Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019
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
−2K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc.20077
−1K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.2007—
0 (this device)K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198720
198940
199110
200010
200110
200420
200520
200720
200810
200910
201210
FIG. 1 — Lineage of K181446, 2000–2019Source: 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? (8)

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 4
…of Device: • PowerPort® Implanted Titanium Port with 8 Fr. Chronoflex® Polyurethane Catheter (K060812) • PowerPort® Implanted Polymeric Port with 8 Fr…
C.R. Bard, Inc.20061
*K063377Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter
Summary page 5
…(K060812) • PowerPort® Implanted Polymeric Port with 8 Fr. Chronoflex® Catheter (K063377) • Titanium PowerPort® isp Implanted Port with 8 Fr. Chronofl…
C.R. Bard, Inc.20077
*K072215Titanium Powerport Isp Implanted Port
Summary page 5
…• Titanium PowerPort® isp Implanted Port with 8 Fr. Chronoflex® Polyurethane Catheter (K072215) • Titanium PowerPort® isp Implanted Port with 6 Fr. Chronofl…
C.R. Bard, Inc.2007—
*K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter
Summary page 5
…• Titanium PowerPort® isp Implanted Port with 6 Fr. Chronoflex® Polyurethane Catheter (K072549) • MRI PowerPort® Implanted Port with 9.6 Fr Silicone Cathete…
C.R. Bard, Inc.20072
*K073423Mri Powerport Implanted Port with 9.6 FR Silicone Catheter
Summary page 5
…Catheter (K072549) • MRI PowerPort® Implanted Port with 9.6 Fr Silicone Catheter (K073423) • PowerPort® Implanted Port with Groshong® Catheter (K081311…
C.R. Bard, Inc.20073
*K081311Powerport Implanted Port with Groshong Catheter
Summary page 5
…Silicone Catheter (K073423) • PowerPort® Implanted Port with Groshong® Catheter (K081311) • PowerPort® duo M.R.I. ® Implanted Port with 9.5 Fr. Dual L…
C.R. Bard, Inc.2008—
*K090512Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex Polyurethane…
Summary page 5
…PowerPort® duo M.R.I. ® Implanted Port with 9.5 Fr. Dual Lumen Chronoflex® Polyurethane Catheter (K090512) • PowerPort® ClearVUE® Slim Implantable Port with 8Fr. Polyu…
C.R. Bard, Inc.20093
*K122899Powerport Clearvue Slim Implantable Port
Summary page 5
…hane Catheter (K090512) • PowerPort® ClearVUE® Slim Implantable Port with 8Fr. Polyurethane Catheter (K122899) Common or Usual Implanted Infusion Port Name: Product Code: LJT – Port & Catheter, Impl…
C.R. Bard, Inc.201211

Also cleared against K060812: 18 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • 17 of the 28 ancestors have a recall of any class.
  • 18 other devices also cite its predicate K060812.

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. 2019, 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 PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a Powerloc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

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
  • 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
  • K091099C-Port - HP Power Injectable PortPhs Medical GmbH · 2009

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K181446 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181446: Bard Power-Injectable Implantable Ports (PowerPorts®).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181446

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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