510(k) · Cleared
Recalled · Class II · 2019Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jan 25, 2007 as substantially equivalent to K060812 (C.R. Bard, Inc., 2006) after a 78-day review. Its family tree reaches back 7 generations to 2000. 11 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 25, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001901 (2000). 20 ancestors in all, the oldest K863606 (1986). 11 later devices descend from it, 8 citing it directly.
- Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- This deviceK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK072549 Titanium Powerport Isp Implanted Port with 6 FR Chronoflex…C.R. Bard, Inc. · 2007 · Recalled
- Descendant · cites it directly · 2 of its ownK072215 Titanium Powerport Isp Implanted PortC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK251253 PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port…Bard Access Systems, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™…Bard Access Systems, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK073423 Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc. · 2007 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc. · 2007 · cites it directly4descendants
- K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc. · 2007 · cites it directly2descendants
- K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc. · 2025 · cites it directly1descendant
- K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc. · 2024 · cites it directly1descendant
- K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −6 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −5 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −4 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −3 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −2 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −1 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| 0 (this device) | K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter | C.R. Bard, Inc. | 2007 | — |
| +1 | K072549 | Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter | C.R. Bard, Inc. | 2007 | 2 |
| +1 | K072215 | Titanium Powerport Isp Implanted Port | C.R. Bard, Inc. | 2007 | — |
| +1 | K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™… | Bard Access Systems, Inc. | 2025 | — |
| +1 | K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim… | Bard Access Systems, Inc. | 2024 | — |
| +1 | K073423 | Mri Powerport Implanted Port with 9.6 FR Silicone Catheter | C.R. Bard, Inc. | 2007 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleSummary page 3…esting demonstrated that the subject PowerPort"' Polymeric Port device is substantially equivalent to the predicate device, the PowerPortt Titanium Port, K060812, concurrence date July 14, 2006.… | 2006 |
What descends from it? (11)
See all 118 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072549 | Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter | 2007 | 4 |
| K072215 | Titanium Powerport Isp Implanted Port | 2007 | 2 |
| K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™… | 2025 | 1 |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable… | 2024 | 1 |
| K073423 | Mri Powerport Implanted Port with 9.6 FR Silicone Catheter | 2007 | 1 |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG… | 2023 | 0 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | 2019 | 0 |
| K133335 | Powerport Implantable Port | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2019 | Class II | Z-0582-2020 | Process control | Complaints received that products packaged with the incorrect introducer sheath size. |
| Jun 25, 2018 | Class II | Z-2080-2019 | Device Design | Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA"… |
| Feb 8, 2018 | Class II | Z-1766-2018 | Error in labeling | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. |
| Feb 8, 2018 | Class II | Z-1761-2018 | Error in labeling | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. |
| Feb 8, 2018 | Class II | Z-1767-2018 | Error in labeling | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. |
| Feb 8, 2018 | Class II | Z-1772-2018 | Error in labeling | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. |
| Feb 8, 2018 | Class II | Z-1760-2018 | Error in labeling | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 11 of the 20 ancestors have a recall of any class.
- Of its descendants, K072549 (C.R. Bard, Inc., 2007) has gone furthest, with 4 descendants of its own.
- 18 other devices also cite its predicate K060812.
How does its category compare?
All LJT devicesLJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The PowerPort TM Implanted Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the PowerLocTM 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.
https://510kreport.com/device/K063377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063377
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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