510(k) · Cleared
ClearedPowerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Oct 20, 2005 as substantially equivalent to K033389 (C.R. Bard, Inc., 2004) and 6 other predicates after a 90-day review. Its family tree reaches back 6 generations to 2000. 17 of the 138 devices in its family, counting itself, have a Class I recall. 119 later devices descend from it.
- Decided
- Oct 20, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K001901 (2000). 18 ancestors in all, the oldest K830256 (1983). 119 later devices descend from it, 10 citing it directly. 17 of the 138 devices in this family, counting this one, have a Class I recall.
- 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 backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 2 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 1 generation backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- This deviceK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- Descendant · cites it directly · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- Descendant · 2 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009
- Descendant · cites it directly · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 2 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 119 · See all- K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · cites it directly66descendants
- K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · cites it directly47descendants
- K091953Pro-PiccMedcomp · 2009 · 2 generations on29descendants
- K101326NMI ICNavilyst Medical, Inc. · 2010 · cites it directly26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 2 generations on23descendants
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 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −2 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −1 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| 0 (this device) | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| +1 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| +1 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| +2 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| +1 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +2 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 4 | 1 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 1 |
| 2011 | 4 | 0 |
| 2012 | 16 | 3 |
| 2013 | 13 | 2 |
| 2014 | 12 | 2 |
| 2015 | 7 | 2 |
| 2016 | 13 | 2 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 1 |
| 2022 | 3 | 1 |
| 2023 | 3 | 0 |
| 2025 | 6 | 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.
17 devices in this family have a Class I recall. 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K033389 | Powerpicc Catheters, Models 3175155, 3175135Summary page 2…Clearance Date 5 Fr Single Lumen (SL) Power PICC M T K033389 3/19/2004 6 Fr Dual (DL) Power PICCTM Lumen… | 2004 |
| * | K050931 | 6 FR DL Powerpicc CatheterSummary page 2…K033389 3/19/2004 6 Fr Dual (DL) Power PICCTM Lumen K050931 6/15/2005 3, 4, 5 Fr Single Lumen (SL) and 4, 5, 6 K034019 1/21/2004… | 2005 |
| * | K034019 | Poly Per-Q-Cath Picc CathetersSummary page 2…ower PICCTM Lumen K050931 6/15/2005 3, 4, 5 Fr Single Lumen (SL) and 4, 5, 6 K034019 1/21/2004 Fr Dual Lumen (DL) Poly Per-Q-Cath® 6 Fr Triple Lumen (TL) Poly Per-Q-… | 2004 |
| * | K043502 | 6 FR Poly Per-Q-Cath Triple Lumen PiccSummary page 2…(SL) and 4, 5, 6 K034019 1/21/2004 Fr Dual Lumen (DL) Poly Per-Q-Cath® 6 Fr Triple Lumen (TL) Poly Per-Q- K043502 1/14/2005 Cath® 5 Fr Single Lumen (SL) PowerHohn T M K050185… | 2005 |
| * | K050185 | Powerhohn and Powerline CathetersSummary page 2…6 Fr Triple Lumen (TL) Poly Per-Q- K043502 1/14/2005 Cath® 5 Fr Single Lumen (SL) PowerHohn T M K050185 5/26/2005 and PowerLine' T M 6 Fr Dual Lumen (DL) PowerHohnm and K051417… | 2005 |
| * | K051417 | 6 FR FL Powerhohn and Powerline CatheterSummary page 2…ngle Lumen (SL) PowerHohn T M K050185 5/26/2005 and PowerLine' T M 6 Fr Dual Lumen (DL) PowerHohnm and K051417 6/30/2005 PowerLineT M 5.3 Predicate Devices The predicate devices are: Device Name:… | 2005 |
| * | K021557 | Spectrum Silicone CatheterSummary page 3…510(k) Predicate Device Name 510(k) Clearance Date Cook Turbo-Flo 4 Fr Single Lumen (SL) K021557 5/30/2003 and 5 Fr Dual Lumen (DL) PICC Cook Triple Lumen 9 Fr Triple Lumen K02… | 2003 |
What descends from it? (119)
See all 11910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | 2007 | 66 |
| K061179 | Powerhickman Long-Term Intravascular Catheter | 2006 | 47 |
| K101326 | NMI IC | 2010 | 26 |
| K080604 | Pressure Injfectable Picc | 2008 | 18 |
| K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | 2009 | 12 |
| K062579 | Omnipicc P.I. | 2006 | 10 |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen | 2009 | 9 |
| K093927 | 6F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central… | 2010 | 6 |
| K102159 | Powerpicc SV Catheters | 2010 | 5 |
| K072230 | Powerpicc Solo | 2007 | 5 |
Has anything in its family been recalled? (17 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 3 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
Nearest 12 of 17 shown.
Nearest 5 of 17; all are on the web page.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 9 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K070996 (C.R. Bard, Inc., 2007) has gone furthest, with 66 descendants of its own.
- 10 other devices also cite its predicate K033389.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. The PowerPICC catheter is indicated for short or long term peripheral…
Read the full statement (305 words)
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The PowerPICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Poly Per-Q-Cath®3 Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Power-Hohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, power injection of contrast media and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the Power-Hohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051991
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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