510(k) · Cleared
Recalled · Class II · 20263F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc (Bard Has Joined Bd) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Apr 26, 2018 as substantially equivalent to K162443 (C.R. Bard, Inc., 2016) and 1 other predicate after a 56-day review. Its family tree reaches back 11 generations to 2000. 2 of the 32 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Apr 26, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001901 (2000). 31 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK102159 Powerpicc SV CathetersC.R. Bard, Inc. · 2010 · Recalled
- 2 generations backK162443 PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · Recalled
- 1 generation backK162441 PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017
- This deviceK180548 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F…C.R. Bard, Inc (Bard Has Joined Bd) · 2018
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 6 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 5 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 4 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 3 generations backK102159 Powerpicc SV CathetersC.R. Bard, Inc. · 2010 · Recalled
- 2 generations backK162443 PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · Recalled
- 1 generation backK162441 PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017
- This deviceK180548 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F…C.R. Bard, Inc (Bard Has Joined Bd) · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −6 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −5 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −4 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| −3 | K102159 | Powerpicc SV Catheters | C.R. Bard, Inc. | 2010 | 3 |
| −2 | K162443 | PowerPICC Provena Catheters | C.R. Bard, Inc. | 2016 | 1 |
| −1 | K162441 | PowerPICC Provena Catheters with SOLO Valve Technology | C.R. Bard, Inc. | 2017 | — |
| 0 (this device) | K180548 | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen… | C.R. Bard, Inc (Bard Has Joined Bd) | 2018 | — |
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 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K162443 | PowerPICC Provena CathetersSummary page 5…taneous, Implanted, Long–term intravascular catheter Predicate Devices Product Code/Regulation: LJS/21 CFR §880.5970 Premarket Notification #: K162443 (PowerPICC Provena) K162441 (PowerPICC Provena Catheters with SOLO2 Valve Technol… | 2016 |
| * | K162441 | PowerPICC Provena Catheters with SOLO Valve TechnologySummary page 5…duct Code/Regulation: LJS/21 CFR §880.5970 Premarket Notification #: K162443 (PowerPICC Provena) K162441 (PowerPICC Provena Catheters with SOLO2 Valve Technology) Manufacturer: Bard Access Systems, In… | 2017 |
| † | K072230 | Powerpicc Solo | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2664-2026 | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
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 · 5 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 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K162443.
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. 2018, 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 Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. The PowerPICC Provena Catheters are indicated for short or long-term…
Read the full statement (110 words)
The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180548: 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180548
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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