510(k) · Cleared
Recalled · Class I · 2026Arrw Evolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International (Subsidiary of Teleflex Inc.) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on May 10, 2012 as substantially equivalent to K100635 (Arrow Intl., Inc., 2010) and 1 other predicate after a 223-day review. Its family tree reaches back 9 generations to 2000. 9 of the 40 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 11 times, including a Class I recall.
- Decided
- May 10, 2012
- Review
- 223 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 11 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 27 ancestors in all, the oldest K830256 (1983). 12 later devices descend from it, 4 citing it directly. 9 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- 1 generation backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- This deviceK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012
- Descendant · cites it directly · 4 of its ownK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- Descendant · 2 generations on · 3 of its ownK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- Descendant · 2 generations on · 2 of its ownK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK122545 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- 1 generation backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- This deviceK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…5 generations back · 2000
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip6 generations back · 1986
- K122545 CG+ Arrow Picc Powered by Arrow VPS Styletcites it directly · 2012
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet2 generations on · 2013
Most influential descendants
Showing 5 of 12 · See all- K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012 · cites it directly4descendants
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 2 generations on3descendants
- K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013 · cites it directly3descendants
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 2 generations on2descendants
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K080604 | Pressure Injfectable Picc | Arrow International, Inc. | 2008 | 1 |
| −1 | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter… | Arrow Intl., Inc. | 2010 | — |
| 0 (this device) | K112896 | Arrw Evolution | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| +1 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| +2 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | Class I |
| +1 | K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. (Subsidiary of Teleflex | 2013 | — |
| +2 | K130876 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. | 2013 | Class I |
| +1 | K122545 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | 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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 1 |
| 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 |
|---|---|---|---|
| * | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Summary page 1…rm intravascular catheter (21 CFR 880.5970, Product Code UJS 3. Predicate Devices Predicate 1: Arrow Antimicrobial Pressure Injectable PICC (K 100635) Predicate 2: P1CC 4 Fr and 5 Fr Single and Dual Lumien (K083763) 4. Device Description The ArrowEVOLUTIONTM Pressure Inj… | 2010 |
| * | K083763 | Zeus CT Picc 4 FR and 5 FR Single and Dual LumenSummary page 1…roduct Code UJS 3. Predicate Devices Predicate 1: Arrow Antimicrobial Pressure Injectable PICC (K 100635) Predicate 2: P1CC 4 Fr and 5 Fr Single and Dual Lumien (K083763) 4. Device Description The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chloragtard Antimicrobial and Antithromnbogenic… | 2009 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | 2012 | 4 |
| K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | 2013 | 3 |
| K122545 | CG+ Arrow Picc Powered by Arrow VPS Stylet Class I | 2012 | 2 |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and… | 2016 | 1 |
Has anything in its family been recalled? (9 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… |
| Apr 23, 2019 | Class II | Z-1819-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1811-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1822-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1820-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Dec 22, 2017 | Class II | Z-1327-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| Nov 27, 2017 | Class II | Z-0996-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Jun 12, 2017 | Class II | Z-2698-2017 | Device Design | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the… |
| May 9, 2017 | Class II | Z-2331-2017 | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Mar 3, 2017 | Class II | Z-1705-2017 | Under Investigation by firm | Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while… |
| 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 11 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 · 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
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · Cites it directly · ◆ 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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 2 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 · 2 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 · 3 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 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 27 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K121501 (Arrow International (Subsidiary of Teleflex Inc.), 2012) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K100635.
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 ArrowEVOLUTIONTM Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 ArrowEVOLUTIONTM Pressure Injectable PICC may not…
Read the full statement (142 words)
The ArrowEVOLUTIONTM Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 ArrowEVOLUTIONTM Pressure Injectable PICC may not exceed 300 psi.
Chlorag+ard Technology 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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112896: Arrw Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112896
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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