510(k) · Cleared
ClearedPowerport 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 Feb 14, 2014 as substantially equivalent to K081311 (C.R. Bard, Inc., 2008) and 8 other predicates after a 108-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Feb 14, 2014
- Review
- 108 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K001901 (2000). 28 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 3 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 2 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 1 generation backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
- This deviceK133335 Powerport Implantable PortC.R. Bard, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −3 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −2 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −1 | K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter | C.R. Bard, Inc. | 2007 | 7 |
| 0 (this device) | K133335 | Powerport Implantable Port | C.R. Bard, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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? (9)
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 |
|---|---|---|---|
| * | K081311 | Powerport Implanted Port with Groshong CatheterSummary page 1…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K(081311 Predicate Devices Trade Name: PowerPort® Polymeric Port with 8 F Single Lumen… | 2008 |
| * | K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterSummary page 1…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K(063377 Bard Access Systems, Inc. Section 5 -510(k) Summary Power a… | 2007 |
| * | K050310 | Bardport Titanium PortsSummary page 2…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K050310 Trade Name: X-PortO Duo Part Common Name: Im… | 2005 |
| * | K032044 | X-Prot Duo PortSummary page 2…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K(032044 Trade Name: BardPort® X-PortO Isp Port Common Name:… | 2003 |
| * | K022983 | Bardport X-Port Isp PortSummary page 2…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K(022983 Trade Name: Plastic Law-Profile Subcutaneous Port Common Name:… | 2002 |
| * | K924250 | Plastic Low Profile Subcutaneous PortSummary page 2…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K924250 Trade Name: Plastic Attachable Dual Port Common Name:… | 1993 |
| * | K912702 | Plastic Attachable Dual PortSummary page 2…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K(912702 Bard Access Systems. Inc. Section 5 - 51 0(k) Summary Power… | 1991 |
| * | K880571 | Cath-Tech Port Implantable Vascular Access SystemSummary page 3…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K880571 Trade Name: Hickman Plastic Subcutaneous Port Common Name:… | 1988 |
| * | K873213 | Hickman Plastic Subcutaneous PortSummary page 3…Product Code: UT Regulation: 21 CFR §880.5965 Premarket Notification: K(873213 PowerPortO PowerPort® Implantable Ports are designed to provide repeated access to t… | 1987 |
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 14 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 14 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K081311.
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. 2014, 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® Implantable 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…
Read the full statement (116 words)
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, 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.
The BardPort, SlimPort, and X-Port implantable ports are 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133335: Powerport 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/K133335
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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