# K081515: Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0

- Pathway: 510(k) (Special)
- Applicant: Neomed, Inc.
- Decided: Jul 21, 2008 after 52 days
- Product code: FOS (Catheter, Umbilical Artery)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944368 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073596: Neomed Single Lumen Umbilical Catheter, Neomed, Inc. (2008) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K081515
Methodology: https://510kreport.com/methodology