510(k) · Cleared
ClearedArrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 27, 2010 as substantially equivalent to K061289 (Arrow International, Inc., 2006) and 1 other predicate after a 175-day review. Its family tree reaches back 8 generations to 2000. 9 of the 40 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Aug 27, 2010
- Review
- 175 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001901 (2000). 25 ancestors in all, the oldest K830256 (1983). 14 later devices descend from it, 2 citing it directly. 9 of the 40 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 deviceK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- Descendant · cites it directly · 12 of its ownK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- Descendant · 3 generations on · 3 of its ownK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- Descendant · 3 generations on · 2 of its ownK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · cites it directly12descendants
- K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations on4descendants
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on3descendants
- K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013 · 2 generations on3descendants
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 3 generations on2descendants
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 | 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) | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter… | Arrow Intl., Inc. | 2010 | — |
| +1 | K112896 | Arrw Evolution | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | Class I |
| +2 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| +3 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | Class I |
| +2 | K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. (Subsidiary of Teleflex | 2013 | — |
| +3 | K130876 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. | 2013 | Class I |
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 | 4 | 2 |
| 2013 | 3 | 2 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 2 |
| 2022 | 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.
9 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 |
|---|---|---|---|
| * | K061289 | Arrow Pressure Injectable PiccSummary page 1…ed Central Catheter Classification Name: Percutaneous, implanted, long-term intravascular catheter 3. Predicate Devices Predicate 1: Pressure Injectable PICC (K061289) Predicate 2: 6 French Triple Lumen Pressure Injectable PICC (KO080604) Predicate 3: ARROWg~ard Blue PLUS® Multi-Lu… | 2006 |
| * | K080604 | Pressure Injfectable PiccSummary page 6…ssure Injectable PICCs are substantially equivalent to the Arrow Pressure injectable PIGCs (K061289) and the Arrow 6 French Triple Lumen Pressure Injectable PICCs (K080604). The subject devices have the same intended use, principles of operation and technological characteristics as the predicat… | 2008 |
| † | K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter | 2000 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 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 · 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
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 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, K112896 (Arrow International (Subsidiary of Teleflex Inc.), 2012) has gone furthest, with 12 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. 2010, 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 Arrow Antimicrobial 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 Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external…
Read the full statement (121 words)
The Arrow Antimicrobial 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 Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100635: Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100635
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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