510(k) · Decided
Recalled · Class II · 2018Arrow Picc-Peripherally Inserted Central Catheter
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 Mar 28, 1994 after a 440-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 28, 1994
- Review
- 440 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 4
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK930129 Arrow Picc-Peripherally Inserted Central CatheterArrow Intl., Inc. · 1994
- Descendant · cites it directly · 1 of its ownK040100 Arrow Echogenic Introducer NeedleArrow Intl., Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK071998 Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK042126 PICCArrow Intl., Inc. · 2004 · Recalled (Class I)
Class I recalls in this family
- K042126 PICCcites it directly · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930129 | Arrow Picc-Peripherally Inserted Central Catheter | Arrow Intl., Inc. | 1994 | — |
| +1 | K040100 | Arrow Echogenic Introducer Needle | Arrow Intl., Inc. | 2004 | — |
| +2 | K071998 | Arrow Echogenic Introducer Needle Component | Arrow Intl., Inc. | 2007 | 2 |
| +1 | K042126 | PICC | Arrow Intl., Inc. | 2004 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 1 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2018 | Class II | Z-2021-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Jan 11, 2017 | Class II | Z-1228-2017 | Device Design | There have been complaints for peel away sheaths flaring |
| Sep 21, 2004 | Not classified | Z-0552-05 | Other | Product was mislabeled for lumen configuration, flow rates, and priming volume. |
| Sep 21, 2004 | Not classified | Z-0551-05 | Other | Product was mislabeled for lumen configuration, flow rates, and priming volume. |
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.
- K042126PICCArrow Intl., Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040100 (Arrow Intl., Inc., 2004) has gone furthest, with 1 descendant of its own.
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) | — |
https://510kreport.com/device/K930129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K930129: Arrow Picc-Peripherally Inserted Central Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930129
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026