510(k) · Cleared
Recalled · Class II · 2014Poly Per-Q-Cath Picc Catheters
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 Jan 21, 2004 as substantially equivalent to K031129 (C.R. Bard, Inc., 2003) after a 28-day review. Its family tree reaches back 3 generations to 2000. 16 of the 243 devices in its family, counting itself, have a Class I recall. 239 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001901 (2000). 239 later devices descend from it, 6 citing it directly. 16 of the 243 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 2 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 1 generation backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- This deviceK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004
- Descendant · cites it directly · 199 of its ownK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- Descendant · 2 generations on · 178 of its ownK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- Descendant · cites it directly · 133 of its ownK043502 6 FR Poly Per-Q-Cath Triple Lumen PiccC.R. Bard, Inc. · 2005
- Descendant · cites it directly · 126 of its ownK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- Descendant · cites it directly · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
Showing 5 of 239 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 239 · See all- K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005 · cites it directly199descendants
- K051672PowerpiccBard Access Systems, Inc. · 2005 · 2 generations on178descendants
- K0435026 FR Poly Per-Q-Cath Triple Lumen PiccC.R. Bard, Inc. · 2005 · cites it directly133descendants
- K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · cites it directly126descendants
- K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · cites it directly119descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −2 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −1 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| 0 (this device) | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | — |
| +1 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| +2 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| +1 | K043502 | 6 FR Poly Per-Q-Cath Triple Lumen Picc | C.R. Bard, Inc. | 2005 | — |
| +1 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| +1 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 19 | 1 |
| 2008 | 12 | 0 |
| 2009 | 11 | 0 |
| 2010 | 12 | 1 |
| 2011 | 12 | 0 |
| 2012 | 20 | 3 |
| 2013 | 18 | 2 |
| 2014 | 18 | 2 |
| 2015 | 12 | 2 |
| 2016 | 15 | 3 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 1 |
| 2022 | 6 | 1 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 16 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
16 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 |
|---|---|---|---|
| * | K031129 | Poly Per-Q-Cath Picc Catheters; Poly RadpiccSummary page 1…Poly Per-Q-Cath P1CC Classification Name: Long Term Intravascular Catheter (80LJS) Premarket Notification: K03 1129, cleared for marketing on May 5, 2003 6.4 Device Description * The Poly Per-Q-Catli PICC Catheters are open-ended… | 2003 |
What descends from it? (239)
See all 2396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050931 | 6 FR DL Powerpicc Catheter | 2005 | 199 |
| K043502 | 6 FR Poly Per-Q-Cath Triple Lumen Picc | 2005 | 133 |
| K051417 | 6 FR FL Powerhohn and Powerline Catheter | 2005 | 126 |
| K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | 2005 | 119 |
| K060341 | Sherlock Tip Location System (TLS) | 2006 | 43 |
| K102159 | Powerpicc SV Catheters | 2010 | 5 |
Has anything in its family been recalled? (16 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2014 | Class II | Z-1271-2015 | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)… |
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.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 3 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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 3 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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K112896Arrw EvolutionArrow 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
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 4 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 · 5 generations on · ◆ in the 2012 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 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
Nearest 12 of 16 shown.
Nearest 5 of 16; all are on the web page.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K050931 (C.R. Bard, Inc., 2005) has gone furthest, with 199 descendants of its own.
- 2 other devices also cite its predicate K031129.
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 Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K034019 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034019: Poly Per-Q-Cath Picc Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034019
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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