510(k) · Cleared
Recalled · Class II · 2019Arrow Pressure Injectable Picc
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 Aug 24, 2006 as substantially equivalent to K041420 (AngioDynamics, Inc., 2004) after a 107-day review. Its family tree reaches back 1 generation to 2004. 8 of the 22 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled 11 times.
- Decided
- Aug 24, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041420 (2004). 20 later devices descend from it, 3 citing it directly. 8 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK041420 Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2004
- This deviceK061289 Arrow Pressure Injectable PiccArrow International, Inc. · 2006
- Descendant · cites it directly · 19 of its ownK073451 Pressure Injectable PiccArrow International, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 18 of its ownK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- Descendant · cites it directly · 14 of its ownK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- Descendant · 2 generations on · 12 of its ownK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K073451Pressure Injectable PiccArrow International, Inc. · 2008 · cites it directly19descendants
- K080604Pressure Injfectable PiccArrow International, Inc. · 2008 · 2 generations on18descendants
- K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc. · 2010 · cites it directly14descendants
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations on12descendants
- K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041420 | Angiodynamics, Inc. Morpheus Picc and Procedure Kit | AngioDynamics, Inc. | 2004 | — |
| 0 (this device) | K061289 | Arrow Pressure Injectable Picc | Arrow International, Inc. | 2006 | — |
| +1 | K073451 | Pressure Injectable Picc | Arrow International, Inc. | 2008 | 6 |
| +2 | K080604 | Pressure Injfectable Picc | Arrow International, Inc. | 2008 | 1 |
| +1 | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter… | Arrow Intl., Inc. | 2010 | — |
| +2 | K112896 | Arrw Evolution | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | Class I |
| +3 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 6 | 3 |
| 2013 | 3 | 2 |
| 2014 | 2 | 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.
8 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 |
|---|---|---|---|
| * | K041420 | Angiodynamics, Inc. Morpheus Picc and Procedure KitSummary page 1…erm greater than 30 days Legally marketed devices to AngioDynamic's Morpheus TM CT PICC and Procedure Kit which the device is (K041420) and Arrow International's Peripherally Inserted substantially equivalent: Central Catheter (K042126) Description of the dev… | 2004 |
| † | K042126 | PICC | 2004 |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2019 | Class II | Z-1255-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-2020-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1325-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| May 9, 2017 | Class II | Z-2338-2017 | Packaging | The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. |
| Feb 17, 2016 | Class II | Z-2772-2016 | Unknown/Undetermined by firm | Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. |
| Feb 17, 2016 | Class II | Z-2774-2016 | Unknown/Undetermined by firm | Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. |
| Feb 17, 2016 | Class II | Z-2771-2016 | Unknown/Undetermined by firm | Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. |
| Feb 17, 2016 | Class II | Z-2773-2016 | Unknown/Undetermined by firm | Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. |
| Sep 18, 2015 | Class II | Z-0127-2016 | Under Investigation by firm | Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five… |
| Jul 30, 2015 | Class II | Z-2462-2015 | Unknown/Undetermined by firm | the catheter peel-away component hub tabs may prematurely detach. One injury reported. |
| Mar 29, 2010 | Not classified | Z-1682-2010 | Nonconforming Material/Component | Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the… |
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.
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations on · ◆ 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 · 3 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 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 4 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 · 4 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 · 5 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 · 5 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?
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 Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061289: Arrow Pressure Injectable Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061289
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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