510(k) · Cleared
Cleared5 FR Dual Lumen Piper PICC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piper Access, LLC · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Sep 25, 2018 as substantially equivalent to K151985 (C.R. Bard, Inc., 2016) after a 71-day review. Its family tree reaches back 10 generations to 2000. 2 of the 30 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 25, 2018
- Review
- 71 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001901 (2000). 29 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- 2 generations backK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK151985 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016
- This deviceK181904 5 FR Dual Lumen Piper PICCPiper Access, LLC · 2018
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 5 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 4 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 3 generations backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- 2 generations backK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK151985 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016
- This deviceK181904 5 FR Dual Lumen Piper PICCPiper Access, LLC · 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 |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −5 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −4 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −3 | K063848 | Powergroshong Picc Catheter | C.R. Bard, Inc. | 2007 | — |
| −2 | K072230 | Powerpicc Solo | C.R. Bard, Inc. | 2007 | 4 |
| −1 | K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | C.R. Bard, Inc. | 2016 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterSummary page 4…roduct Code: LJS Regulation: 21 CFR §880.5970 Panel: General Hospital Primary Predicate Premarket Notification: K151985 (clearance date June 14, 2016) Trade Name: PowerPICC® EtOH Catheter Manufacturer: Bard Access Sys… | 2016 |
| † | K051672 | Powerpicc | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 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 3 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 29 ancestors have a recall of any class; 2 have a Class I recall.
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 5 FR DL Piper PICC Catheter is indicated for short or long term peripheral access to the central venous system for
intravenous therapy, power injection of contrast media, and prolonged exposure to intraluminal solutions containing up to
70% ethanol. The maximum recommended infusion rate is SmL/sec for power injection of contrast media.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181904: 5 FR Dual Lumen Piper PICC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181904
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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