510(k) · Cleared

Recalled · Class II · 2025

Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR.

K130725510(k) SpecialCleared Apr 17, 201330-day reviewClass II21 CFR 880.5200Recalls 3

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

Covidien Lp, Formerly Registered AS Kendall · FOS Catheter, Umbilical Artery

Cleared on Apr 17, 2013 as substantially equivalent to K850884 (Sherwood Medical Co., 1985) after a 30-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it. It has been recalled 3 times.

Decided: Apr 17, 2013
Review: 30 days
Class: Class II
Product code: FOS
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K850884 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK850884 Argyle Polyurethane Umbilical Vessel CatheterSherwood Medical Co. · 1985
This deviceK130725 Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR…Covidien Lp, Formerly Registered AS Kendall · 2013
Descendant · cites it directly · 0 of its ownK201697 Umbilical Vessels CatheterHaolang Medical USA Corporation · 2021

Most influential descendants

Showing 1 of 1 · See all

K201697Umbilical Vessels CatheterHaolang Medical USA Corporation · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850884	Argyle Polyurethane Umbilical Vessel Catheter	Sherwood Medical Co.	1985	—
0 (this device)	K130725	Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR.	Covidien Lp, Formerly Registered AS Kendall	2013	—
+1	K201697	Umbilical Vessels Catheter	Haolang Medical USA Corporation	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K130725, 1985–2021Source: 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 FOS? 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 FOS device

#1 K201697 Umbilical Vessels Catheterscore 1.6 · 2 generations · no Class I recall

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K850884	Argyle Polyurethane Umbilical Vessel Catheter Summary page 1 …Umbilical Vessel Catheter Classification Name: Intravascular catheter Regulation Number: 880.5200 Product Code: FOS Device Class: 2 3. Predicate Device: K850884 - Argyle Polyurethane Umbilical Vessel Cathetert *The predicate device 510(k), K850884, was submitted by Sherwood Medical Co.;…	Sherwood Medical Co.	1985	—

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
K201697	Umbilical Vessels Catheter	Haolang Medical USA Corporation	2021	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 2, 2025	Class II	Z-1871-2025	Package design/selection	Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
May 2, 2025	Class II	Z-1872-2025	Package design/selection	Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
May 2, 2025	Class II	Z-1873-2025	Package design/selection	Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K201697 (Haolang Medical USA Corporation, 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FOS devices

FOS Catheter, Umbilical Artery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FOS

1in 2021

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOS

Too few FOS 510(k)s in any year since 2007 to give a median.

Recalls per year · FOS

No recall names FOS since 2007.

Adverse event reports per year · FOS

56in 2025

2007high 139 (2017) · low 20 (2023)2025

MAUDE reports naming product code FOS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	26
2008	2	—	42
2009	2	—	40
2010	0	—	94
2011	0	—	74
2012	1	—	70
2013	1	—	95
2014	0	—	69
2015	0	—	81
2016	0	—	115
2017	0	—	139
2018	0	—	84
2019	0	—	64
2020	0	—	43
2021	1	—	49
2022	0	—	38
2023	0	—	20
2024	0	—	52
2025	0	—	56
2026	0	—	—

What is it indicated for?

The Argyle Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130725 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130725: Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130725

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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