# K073596: Neomed Single Lumen Umbilical Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Feb 22, 2008 after 63 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: 1 generation back to K944368 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944368: Catco Silicone Umbilical Vessel Catheter, Catco Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K081515: Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0 (2008), 0 descendants of its own

## Indications for use
The NeoMed Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Source page: https://510kreport.com/device/K073596
Methodology: https://510kreport.com/methodology