# K120304: Footprint Medical Polyurethane Umbilical Catheter

- Pathway: 510(k) (Special)
- Applicant: Footprint Medical, Inc.
- Decided: Mar 1, 2012 after 29 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Source page: https://510kreport.com/device/K120304
Methodology: https://510kreport.com/methodology