510(k) · Cleared
Recalled · Class I · 2026Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 21, 2012 as substantially equivalent to K061289 (Arrow International, Inc., 2006) and 2 other predicates after a 227-day review. Its family tree reaches back 8 generations to 2000. 3 of the 28 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Jun 21, 2012
- Review
- 227 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 6 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 8 generations to K001901 (2000). 25 ancestors in all, the oldest K830256 (1983). 2 later devices descend from it, 2 citing it directly. 3 of the 28 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 backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 1 generation backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- This deviceK113277 Arrowadvantages Pressure Injectable Peripherally Inscrted Central…Arrow International, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK140129 Piccox Peripherally Inserted Pressure Injectable, Central Venous…Icu Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK121941 Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView 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 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −3 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −1 | K080604 | Pressure Injfectable Picc | Arrow International, Inc. | 2008 | 1 |
| 0 (this device) | K113277 | Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits | Arrow International, Inc. | 2012 | — |
| +1 | K140129 | Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry… | Icu Medical, Inc. | 2014 | — |
| +1 | K121941 | Arrow Picc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | 10 |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K061289 | Arrow Pressure Injectable Picc | 2006 |
| * | K073451 | Pressure Injectable PiccSummary page 1…long-term intravascular catheter 3. Predicate Devices Predicate 1: Pressure Injectable P1CC (K(06 1289) Predicate 2: Pressure Injectable P1CC V2.0 (K073451) Predicate 3: 6F 3L Pressure Injectable P1CC (K080604) 4. Device Description The ArrowADVANTAGE fl' Pressure In… | 2008 |
| * | K080604 | Pressure Injfectable PiccSummary page 1…Predicate 1: Pressure Injectable P1CC (K(06 1289) Predicate 2: Pressure Injectable P1CC V2.0 (K073451) Predicate 3: 6F 3L Pressure Injectable P1CC (K080604) 4. Device Description The ArrowADVANTAGE fl' Pressure Injectable P1CC is a short-term or long-term, single use cat… | 2008 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2378-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Dec 20, 2019 | Class II | Z-1254-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-2023-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Jul 25, 2017 | Class II | Z-0602-2018 | Packaging process control | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter.… |
| Jun 1, 2017 | Class II | Z-0182-2018 | Mixed-up of materials/components | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. |
| Oct 16, 2015 | Class II | Z-0207-2016 | Unknown/Undetermined by firm | Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may… |
The 5 latest of 6 recalls; the web page lists all.
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 12 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K140129 (Icu Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061289.
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. 2012, 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 ArrowADVANTAGETM Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the ArrowADVANTAGETM Pressure Injectable PICC may not exceed 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113277: Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113277
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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