510(k) · Cleared
ClearedArgyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 5, 2013 as substantially equivalent to K974015 (Davis & Geck, Inc., 1998) and 2 other predicates after an 82-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Nov 5, 2013
- Review
- 82 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K920755 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK920755 L-Cath Peel Away System CatheterLuther Medical Products, Inc. · 1993 · Recalled
- 1 generation backK042461 Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall · 2004 · Recalled
- This deviceK132567 Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle…Covidien · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920755 | L-Cath Peel Away System Catheter | Luther Medical Products, Inc. | 1993 | 10 |
| −1 | K042461 | Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304 | Kendall | 2004 | 1 |
| 0 (this device) | K132567 | Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle… | Covidien | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
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.
Planning a device in LJS? 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? (3)
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 |
|---|---|---|---|
| * | K974015 | Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick-…Summary page 1…utic Intravascular Catheter Regulation Description: Intravascular Catheter Product Code: FOZ Regulation Number: 880.5200 Device Class: 2 Predicate Device: K97401 5 - Argyle Quick-PICO"' Neonatal/Pediatric Peripherally Inserted Central Catheter and Accessories* *Please note, the predica… | 1998 |
| * | K042461 | Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Summary page 1…ulation Description: Percutaneous, implanted, Long-Term Intravascular Catheter Product Code: US Regulation Number: 880.5970 Device Class: 2 Predicate Device: K042461 and K061 936 - Kendall Argyle 1.9 Fr. Dual Lumen Neonatal/Pediatric Peripherally Inserted Central Catheter 3. Device Descript… | 2004 |
| * | K061936 | Kendall Argyle Neonatal/Pediatric Picc, Model 43311Summary page 1…ription: Percutaneous, implanted, Long-Term Intravascular Catheter Product Code: US Regulation Number: 880.5970 Device Class: 2 Predicate Device: K042461 and K061 936 - Kendall Argyle 1.9 Fr. Dual Lumen Neonatal/Pediatric Peripherally Inserted Central Catheter 3. Device Description: The… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K974015.
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. 2013, 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 catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well as other commonly used intravenous medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132567: Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132567
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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