510(k) · Cleared
Recalled · Class III · 2015Powerpicc Solo
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 5, 2007 as substantially equivalent to K033389 (C.R. Bard, Inc., 2004) and 7 other predicates after a 56-day review. Its family tree reaches back 8 generations to 2000. 3 of the 33 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 5, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 4
- Predicates
- 8
Its longest line of descent runs back 8 generations to K001901 (2000). 27 ancestors in all, the oldest K830256 (1983). 5 later devices descend from it, 4 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 3 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 2 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 1 generation backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- This deviceK072230 Powerpicc SoloC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK151985 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK210264 BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK181904 5 FR Dual Lumen Piper PICCPiper Access, LLC · 2018
- Descendant · cites it directly · 0 of its ownK141633 Pro-Picc with Valve TechnologyMedical Components, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK130897 Medcomp Vascu-Picc with ValveMedcomp ( Medical Components) · 2013
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016 · cites it directly1descendant
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · cites it directly0descendants
- K1819045 FR Dual Lumen Piper PICCPiper Access, LLC · 2018 · 2 generations on0descendants
- K141633Pro-Picc with Valve TechnologyMedical Components, Inc. · 2014 · cites it directly0descendants
- K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components) · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −3 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −2 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −1 | K063848 | Powergroshong Picc Catheter | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K072230 | Powerpicc Solo | C.R. Bard, Inc. | 2007 | — |
| +1 | K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | C.R. Bard, Inc. | 2016 | — |
| +1 | K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | 2021 | Class I |
| +2 | K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | 2018 | — |
| +1 | K141633 | Pro-Picc with Valve Technology | Medical Components, Inc. | 2014 | — |
| +1 | K130897 | Medcomp Vascu-Picc with Valve | Medcomp ( Medical Components) | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 1 |
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.
3 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? (8)
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 1…e below Predicate Device Name 510(k) Concurrence Date 5 Fr Single Lumen (SL) K033389 March 14, 2004 PowerPICC® catheter Predicate 6 Fr Dual Lumen (DL)… | 2004 |
| * | K050931 | 6 FR DL Powerpicc CatheterSummary page 1…PowerPICC® catheter Predicate 6 Fr Dual Lumen (DL) Devices PowerPICC® catheter K050931 June 15, 2005 5 Fr Dual Lumen ®… | 2005 |
| * | K051672 | PowerpiccSummary page 1…2005 5 Fr Dual Lumen ® (DL) K051672 November 23, 2005 PowerPICC catheter 6 Fr Triple Lumen… | 2005 |
| * | K053501 | PowerpiccSummary page 1…Power~~dg) PawerPICC® ctheter catheter K053501 January t13, 2006 4 Fr Single Lumen (SL) PowerP… | 2006 |
| * | K070996 | 4 FR Single Lumen (SL) Powerpicc CatheterSummary page 1…PowerPl~d) PowerPICC® cateter catheter K070996 May 8, 2007 ________… | 2007 |
| * | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineSummary page 1…________ PowerPICC*, Poly Per-Q-Cath, 6 Fr TL Poly Per-Q-Cath, K051991 October 20, 2005 PowerHohn and PowerLines Trade Name:… | 2005 |
| * | K063848 | Powergroshong Picc CatheterSummary page 1…e below Predicate Device Name 510(k) Concurrence Date 5 Fr SL PowerGroshongTM K063848 April 4, 2007 PICC Catheter Bard Access Systems… | 2007 |
| * | K021704 | Vaxcel Picc with Pasv Valve TechnologySummary page 2…Date:J Concurrence Vaxcel PICC with PASV® K021704 2 Valve Technology Classification 21 CFR 880.5970, Class II,80LJS - Long… | 2002 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2015 | Class III | Z-2049-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Class III | Z-2048-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Class III | Z-2047-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Class III | Z-2050-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
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 · 3 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 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 13 of the 27 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K151985 (C.R. Bard, Inc., 2016) has gone furthest, with 1 descendant 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. 2007, 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 SOLOTM 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 for power injection of contrast media. 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/K072230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072230: Powerpicc Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072230
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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