510(k) · Cleared

Recalled · 2005

Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304

K042461510(k) AbbreviatedCleared Dec 10, 200491-day reviewClass II21 CFR 880.5970Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kendall · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Dec 10, 2004 as substantially equivalent to K920755 (Luther Medical Products, Inc., 1993) and 3 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.

Decided: Dec 10, 2004
Review: 91 days
Class: Class II
Product code: LJS
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K920755 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK920755 L-Cath Peel Away System CatheterLuther Medical Products, Inc. · 1993 · Recalled
This deviceK042461 Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall · 2004
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	K920755	L-Cath Peel Away System Catheter	Luther Medical Products, Inc.	1993	10
0 (this device)	K042461	Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304	Kendall	2004	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K042461, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K920755	L-Cath Peel Away System Catheter Summary page 4 …herally Inserted Central Catheter (PICC) Classification Name: Long-term catheters (30 days or more) Predicate Devices: L-Cath Peel Away System (K920755) VYGON Premi-Cath - Long Term Catheter (K954302)…	Luther Medical Products, Inc.	1993	10
*	K954302	Vygon Premi-Cath - Long Term Catheter Summary page 4 …Predicate Devices: L-Cath Peel Away System (K920755) VYGON Premi-Cath - Long Term Catheter (K954302) Neo-PICC (K970434) Kendall Argyle 2.0 Fr. Single Lumen PICC…	Vygon Corp.	1996	1
*	K970434	Neo-Picc Summary page 4 …tem (K920755) VYGON Premi-Cath - Long Term Catheter (K954302) Neo-PICC (K970434) Kendall Argyle 2.0 Fr. Single Lumen PICC (K9740 15) Des…	Klein-Baker Medical, Inc.	1997	1
*	K974015	Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick-… Summary page 4 …(K954302) Neo-PICC (K970434) Kendall Argyle 2.0 Fr. Single Lumen PICC (K9740 15) Description oftheDevice: The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is…	Davis & Geck, Inc.	1998	—

Also cleared against K920755: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132567	Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted…	Covidien	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 27, 2005	Not classified	Z-0932-05	Other	Holes in thermoformed tray compromising the sterility of the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

3 of the 4 ancestors have a recall of any class.
Of its descendants, K132567 (Covidien, 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K920755.

How does its category compare?

All LJS devices

LJS 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

2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007high 284 (2021) · low 31 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJS

5in 2023

2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007high 4,372 (2025) · low 369 (2008)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/K042461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042461: Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042461

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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