510(k) · Cleared
Recalled · Class II · 2018Peripherally Inserted Medline 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 4, 1997 after a 197-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 4, 1997
- Review
- 197 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 1
- Predicates
- 1
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK963257 Peripherally Inserted Medline CatheterArrow Intl., Inc. · 1997
- Descendant · cites it directly · 2 of its ownK021130 Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK161313 ARROW Pressure Injectable Midline Catheter with Chlorag+ard…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK070451 Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK213855 Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK193158 ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020
Class I recalls in this family
- K213855 Arrow Pressure Injectable Midline Catheter2 generations on · 2022
Most influential descendants
Showing 5 of 5 · See all- K021130Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 2003 · cites it directly2descendants
- K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · cites it directly1descendant
- K070451Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007 · 2 generations on1descendant
- K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022 · 2 generations on0descendants
- K193158ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963257 | Peripherally Inserted Medline Catheter | Arrow Intl., Inc. | 1997 | — |
| +1 | K021130 | Specath Central Venous Catheter Kits | Special Medical Co., Ltd. | 2003 | — |
| +1 | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and… | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | 2 |
| +2 | K070451 | Able Central Venous Catheter | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2007 | — |
| +2 | K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | 2022 | Class I |
| +3 | K193158 | ACENT™ Central Venous Catheter | Global Medikit Limited | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 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.
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K960113 | Menlo Care Landmark Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (5)
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 |
|---|---|---|---|---|
| May 17, 2018 | Class II | Z-2385-2018 | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. |
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.
- 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
What does this lineage say?
- Of its descendants, K021130 (Special Medical Co., Ltd., 2003) has gone furthest, with 2 descendants 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/K963257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963257: Peripherally Inserted Medline Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963257
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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