510(k) · Decided
Recalled · Class I · 2026PICC
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, 2004 as substantially equivalent to K930129 (Arrow Intl., Inc., 1994) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1994. 2 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Aug 27, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 4 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930129 (1994). 2 ancestors in all. No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK930129 Arrow Picc-Peripherally Inserted Central CatheterArrow Intl., Inc. · 1994 · Recalled
- This deviceK042126 PICCArrow Intl., Inc. · 2004
Class I recalls in this family
- K003006 Two-Lumen Picc with Blue Flextip Catheter and…direct predicate · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930129 | Arrow Picc-Peripherally Inserted Central Catheter | Arrow Intl., Inc. | 1994 | 4 |
| 0 (this device) | K042126 | PICC | Arrow Intl., Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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.
2 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 |
|---|---|---|---|
| * | K930129 | Arrow Picc-Peripherally Inserted Central CatheterSummary page 1…30 days Legally marketed devices to Arrow International's Peripherally Inserted Central which the device is Catheter (K930129) and Two Lumen PICC with Blue substantially equivalent: FlexTip® Catheter with Integral Needle Protection… | 1994 |
| * | K003006 | Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionSummary page 1…Catheter (K930129) and Two Lumen PICC with Blue substantially equivalent: FlexTip® Catheter with Integral Needle Protection (K003006) Description of the device: The Arrow International Peripherally Inserted Central Cathe… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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… |
| Aug 27, 2015 | Class II | Z-2825-2015 | Process control | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products. |
| 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. |
| Feb 11, 2009 | Not classified | Z-1503-2009 | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
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.
- K003006Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K930129.
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?
A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042126: PICC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042126
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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