510(k) · Cleared

Cleared

Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0

K081515510(k) SpecialCleared Jul 21, 200852-day reviewClass II21 CFR 880.5200

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

Neomed, Inc. · FOS Catheter, Umbilical Artery

Cleared on Jul 21, 2008 as substantially equivalent to K073596 (Neomed, Inc., 2008) after a 52-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jul 21, 2008
Review: 52 days
Class: Class II
Product code: FOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K944368 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944368 Catco Silicone Umbilical Vessel CatheterCatco Medical, Inc. · 1995
1 generation backK073596 Neomed Single Lumen Umbilical CatheterNeomed, Inc. · 2008
This deviceK081515 Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0Neomed, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944368	Catco Silicone Umbilical Vessel Catheter	Catco Medical, Inc.	1995	—
−1	K073596	Neomed Single Lumen Umbilical Catheter	Neomed, Inc.	2008	—
0 (this device)	K081515	Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0	Neomed, Inc.	2008	—

FIG. 1 — Lineage of K081515, 1995–2008Source: 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
*	K073596	Neomed Single Lumen Umbilical Catheter Summary page 1 …0.5200 CLASSIFICATION AND PRODUCT Product Code: 80 FOS CODE PREDICATE NeoMed Single Lumen Umbilical Catheter (K073596) DEVICE NAME SUBSTANTIAL EQUIVALENCE: The NeoMed Dual Lumen Umbilical Catheter is substantially equivalent to the NeoM…	Neomed, Inc.	2008	—

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 13 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All FOS devices

FOS Catheter, Umbilical Artery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081515: Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081515

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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