510(k) · Cleared
Recalled · Class II · 2021Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex Polyurethane 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 Mar 27, 2009 after a 29-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 27, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK090512 Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen…C.R. Bard, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK252478 Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™…Bard Access Systems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK181446 Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK153238 Dignity Dual PortMedcomp ( Medical Components) · 2016
Most influential descendants
Showing 3 of 3 · See all- K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…Bard Access Systems, Inc. · 2025 · cites it directly0descendants
- K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019 · cites it directly0descendants
- K153238Dignity Dual PortMedcomp ( Medical Components) · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090512 | Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex… | C.R. Bard, Inc. | 2009 | — |
| +1 | K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT… | Bard Access Systems, Inc. | 2025 | — |
| +1 | K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | 2019 | — |
| +1 | K153238 | Dignity Dual Port | Medcomp ( Medical Components) | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | — | PowerPort M.R.I. Implanted Port with 8.0 Fr. ChronoFlex Polyurethane Catheter Named without a submission number | |
| * | — | X-Port duo Implanted Port with 9.5 Fr. Dual Lumen (D/L) ChronoFlex Polyurethane Catheter Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2021 | Class II | Z-1550-2021 | Process control | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| Mar 25, 2021 | Class II | Z-1551-2021 | Process control | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| Mar 25, 2021 | Class II | Z-1552-2021 | Process control | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K252478 (Bard Access Systems, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2009, 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' 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 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.
https://510kreport.com/device/K090512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090512: Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex Polyurethane Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090512
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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