510(k) · Cleared
Recalled · Class II · 2020Powerport Clearvue Slim Implantable Port
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 Nov 15, 2012 after a 55-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 11 times.
- Decided
- Nov 15, 2012
- Review
- 55 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 11
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK122899 Powerport Clearvue Slim Implantable PortC.R. Bard, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™…Bard Access Systems, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260916 FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK232737 PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™…Bard Peripheral Vascular, Inc. · 2023
- 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 ownK150514 Power-Injectable Implantable Ports with ChronoFlex Polyurethane…C.R. Bard, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc. · 2024 · cites it directly1descendant
- K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026 · 2 generations on0descendants
- K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc. · 2023 · cites it directly0descendants
- K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. · 2019 · cites it directly0descendants
- K150514Power-Injectable Implantable Ports with ChronoFlex Polyurethane CathetersC.R. Bard, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122899 | Powerport Clearvue Slim Implantable Port | C.R. Bard, Inc. | 2012 | — |
| +1 | K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim… | Bard Access Systems, Inc. | 2024 | — |
| +2 | K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access, Inc. | 2026 | — |
| +1 | K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™… | Bard Peripheral Vascular, Inc. | 2023 | — |
| +1 | K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | 2019 | — |
| +1 | K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | — | Titanium PowerPort® ISP with 5F Polyurethane Catheter Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable… | 2024 | 1 |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG… | 2023 | 0 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | 2019 | 0 |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2020 | Class II | Z-1964-2020 | Employee error | The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. |
| 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-1768-2018 | 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-1770-2018 | 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-1763-2018 | 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-1769-2018 | 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-1765-2018 | 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-1762-2018 | 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-1773-2018 | 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-1764-2018 | 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-1771-2018 | 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 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K242328 (Bard Access Systems, Inc., 2024) has gone furthest, with 1 descendant 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. 2012, 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® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter 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 (SIS), 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/K122899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122899: Powerport Clearvue Slim Implantable Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122899
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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