510(k) · Cleared
ClearedPowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
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 Jun 14, 2016 as substantially equivalent to K051672 (Bard Access Systems, Inc., 2005) and 3 other predicates after a 333-day review. Its family tree reaches back 9 generations to 2000. 2 of the 30 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 14, 2016
- Review
- 333 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K001901 (2000). 28 ancestors in all, the oldest K830256 (1983). 1 later device descends from it, 1 citing it directly. 2 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 2 generations backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
- This deviceK151985 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK181904 5 FR Dual Lumen Piper PICCPiper Access, LLC · 2018
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 2 generations backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
- This deviceK151985 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K1819045 FR Dual Lumen Piper PICCPiper Access, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −2 | K063848 | Powergroshong Picc Catheter | C.R. Bard, Inc. | 2007 | — |
| −1 | K072230 | Powerpicc Solo | C.R. Bard, Inc. | 2007 | 4 |
| 0 (this device) | K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | C.R. Bard, Inc. | 2016 | — |
| +1 | K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
2 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? (4)
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 5…Classification Name: Percutaneous, Implanted, Long –term intravascular catheter Premarket Notification: K051672 Manufacturer: Bard Access Systems, Inc. Predicate Trade Name: 6F TL PowerPICC® Cathe… | 2005 |
| * | K053501 | PowerpiccSummary page 5…e: Percutaneous, Implanted, Long –term intravascular Predicate catheter Devices Premarket Notification: K053501 Manufacturer: Bard Access Systems, Inc. Predicate Trade Name: 4F Single Lumen (SL) P… | 2006 |
| * | K070996 | 4 FR Single Lumen (SL) Powerpicc CatheterSummary page 5…Classification Name: Percutaneous, Implanted, Long –term intravascular catheter Premarket Notification: K070996 Manufacturer: Bard Access Systems, Inc. Predicate Trade Name: PowerPICC… | 2007 |
| * | K072230 | Powerpicc SoloSummary page 6…Classification Name: Percutaneous, Implanted, Long –term intravascular catheter Premarket Notification: K072230 Manufacturer: Bard Access Systems, Inc. Bard Access Systems, Inc.’s PowerPICC® EtOH and Po… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181904 | 5 FR Dual Lumen Piper PICC | 2018 | 0 |
Has anything in its family been recalled? (2 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 · 4 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 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 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; 2 have a Class I recall.
- Of its descendants, K181904 (Piper Access, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K051672.
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. 2016, this device’s year, is highlighted.
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®EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, 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. For central venous pressure monitoring, it is recommended that a catheter…
Read the full statement (198 words)
The PowerPICC®EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, 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. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Catheter Size — Maximum Flow Rate
4F Single Lumen — 5 ml/sec
5F Dual Lumen — 5 ml/sec
5F Triple Lumen — 4 ml/sec
The PowerPICC SOLO®2 EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, 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. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Catheter Size — Maximum Flow Rate
4F Single Lumen — 5 ml/sec
5F Dual Lumen — 5 ml/sec
5F Triple Lumen — 4 ml/sec
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151985: PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151985
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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