# K201697: Umbilical Vessels Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Haolang Medical USA Corporation
- Decided: May 6, 2021 after 318 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 K850884 (1985). 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)
- K130725: Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR., Covidien Lp, Formerly Registered AS Kendall (2013) Summary page 4.

## Indications for use
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients: Via the umbilical artery: ---sampling of blood, ---measurement of intravascular arterial pressure. Via the umbilical vein: ---infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).

Source page: https://510kreport.com/device/K201697
Methodology: https://510kreport.com/methodology