510(k) · Cleared
ClearedPowerpicc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jan 13, 2006 as substantially equivalent to K043502 (C.R. Bard, Inc., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 6 generations to 2000. 14 of the 117 devices in its family, counting itself, have a Class I recall. 108 later devices descend from it.
- Decided
- Jan 13, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001901 (2000). 8 ancestors in all. 108 later devices descend from it, 12 citing it directly. 14 of the 117 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 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 deviceK053501 PowerpiccBard Access Systems, Inc. · 2006
- Descendant · cites it directly · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 31 of its ownK081904 Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full…Medcomp · 2008 · Recalled
- Descendant · 2 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009
- Descendant · 2 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 3 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 108 · See all- K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · cites it directly66descendants
- K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp · 2008 · cites it directly31descendants
- K091953Pro-PiccMedcomp · 2009 · 2 generations on29descendants
- K101326NMI ICNavilyst Medical, Inc. · 2010 · 2 generations on26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 3 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 | 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) | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| +1 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| +1 | K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) | Medcomp | 2008 | 2 |
| +2 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| +2 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +3 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 1 |
| 2011 | 2 | 0 |
| 2012 | 15 | 3 |
| 2013 | 12 | 2 |
| 2014 | 10 | 2 |
| 2015 | 7 | 2 |
| 2016 | 10 | 2 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 1 |
| 2022 | 3 | 1 |
| 2023 | 2 | 0 |
| 2025 | 5 | 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.
14 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? (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 |
|---|---|---|---|
| * | K043502 | 6 FR Poly Per-Q-Cath Triple Lumen PiccSummary page 1…Peripherally Inserted Central Catheter (P1CC) Classification Name: Long Terrn Intravascular Catheter (80 US) Premarket Notification: K043502, concurrence date-January 14, 2005 lDevice Name: 5 Fr DL PoxverPlCCt Catheter Trade Name:… | 2005 |
| * | K051672 | PowerpiccSummary page 2…ded use has not changed. 6.6 Indications for Use The indications for use have not changed from the predicate 5 Fr DL PowerPICC t catheter (K05 1672). The PowerPICC® catheter is indicated for short or long termi peripheral access to the central venous syste… | 2005 |
What descends from it? (108)
See all 10812 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 |
| K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) | 2008 | 31 |
| K080604 | Pressure Injfectable Picc | 2008 | 18 |
| K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | 2009 | 12 |
| K093927 | 6F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central… | 2010 | 6 |
| K082047 | Securacath Catheter, Model SPK01 | 2008 | 6 |
| K063848 | Powergroshong Picc Catheter | 2007 | 6 |
| K102159 | Powerpicc SV Catheters | 2010 | 5 |
| K072230 | Powerpicc Solo | 2007 | 5 |
| K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | 2016 | 1 |
Has anything in its family been recalled? (14 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.
- 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
- 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
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
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.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K070996 (C.R. Bard, Inc., 2007) has gone furthest, with 66 descendants of its own.
- 3 other devices also cite its predicate K043502.
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 PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053501: Powerpicc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053501
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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