510(k) · Cleared
ClearedKendall Argyle Neonatal/Pediatric Picc, Model 43311
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 9, 2006 as substantially equivalent to K974015 (Davis & Geck, Inc., 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Aug 9, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974015 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK974015 Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc…Davis & Geck, Inc. · 1998
- This deviceK061936 Kendall Argyle Neonatal/Pediatric Picc, Model 43311The Kendall Company · 2006
- Descendant · cites it directly · 0 of its ownK132567 Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle…Covidien · 2013
Most influential descendants
Showing 1 of 1 · See all- K132567Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted…Covidien · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974015 | Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle… | Davis & Geck, Inc. | 1998 | — |
| 0 (this device) | K061936 | Kendall Argyle Neonatal/Pediatric Picc, Model 43311 | The Kendall Company | 2006 | — |
| +1 | K132567 | Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle… | Covidien | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974015 | Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick-…Summary page 1…CC) Classification Name: Long-term catheters (30 days or more) Predicate Devices: "Kendall Argyle 2.0 Fr. Single Lumen PICC (K974015) Kendall Argyle 1.9 Fr. Dual Lumen PICC (K42461) Description of the Dev… | 1998 |
| Kept off the family tree | K042461 | FDA’s K042461 is Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132567 | Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted… | 2013 | 0 |
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?
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 catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a 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 other commonly used intravenous medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061936: Kendall Argyle Neonatal/Pediatric Picc, Model 43311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061936
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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