510(k) · Cleared
Recalled · Class II · 2014Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple
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 Jul 14, 2006 as substantially equivalent to K051672 (Bard Access Systems, Inc., 2005) and 2 other predicates after a 112-day review. Its family tree reaches back 6 generations to 2000. 66 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001901 (2000). 19 ancestors in all, the oldest K863606 (1986). 66 later devices descend from it, 19 citing it directly.
- Root · 6 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 4 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 3 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 2 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 1 generation backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- This deviceK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006
- Descendant · cites it directly · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- Descendant · cites it directly · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- Descendant · cites it directly · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- Descendant · cites it directly · 11 of its ownK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp · 2007 · cites it directly20descendants
- K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · cites it directly20descendants
- K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · cites it directly18descendants
- K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · cites it directly13descendants
- K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −5 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −4 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −3 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −2 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −1 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| 0 (this device) | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | — |
| +1 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| +1 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| +1 | K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems… | Smiths Medical MD, Inc. | 2007 | — |
| +1 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 2 |
| +1 | K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter | C.R. Bard, Inc. | 2007 | 7 |
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 | 11 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K051672 | PowerpiccSummary page 1…Term Intravascular Catheter (21 CFR §880.5970) Classification Panel: General Hospital Premarket Notification: K051672, Substantial Equivalence: November 23, 2005… | 2005 |
| * | K050310 | Bardport Titanium PortsSummary page 2…ion Port & Catheter (21 CFR §880.5965) Classification Panel: General Hospital Premarket Notification: K050310, Substantial Equivalence: April 18, 2005 PowerLocTM SIS Device Predicate: Trade/Device Name: MiniL… | 2005 |
| * | K050600 | Miniloc Safety Infusion SetSummary page 2…Administration Set (21 CFR §880.5440) Classification Panel: General Hospital Premarket Notification: K050600, Substantial Equivalence: May 12, 2005 11.4 Device Description PowerPortTM Implanted Titanium Port Device * Th… | 2005 |
What descends from it? (66)
See all 6619 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | 2007 | 20 |
| K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | 2007 | 20 |
| K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power… | 2007 | 18 |
| K073050 | Safestep Max Power-Injectable Infusion Set | 2008 | 13 |
| K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter | 2007 | 11 |
| K071846 | Modification to EZ Huber Safety Infusion Set | 2007 | 8 |
| K091099 | C-Port - HP Power Injectable Port | 2009 | 5 |
| K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set | 2007 | 5 |
| K082306 | Powerloc Clear Safety Infusion Set | 2008 | 4 |
| K072549 | Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter | 2007 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2014 | Class II | Z-1272-2015 | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 10 of the 19 ancestors have a recall of any class.
- Of its descendants, K070003 (Medcomp, 2007) has gone furthest, with 20 descendants of its own.
- 8 other devices also cite its predicate K051672.
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.
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, IV. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum…
Read the full statement (184 words)
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, IV. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the 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 PowerLoc™ Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports.
The PowerLoc™ Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with the PowerPort™ device, the PowerLoc™ Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles, and 2 ml/s for 22 Ga. needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060812
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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