# K242255: Qitexio® 4-Way Stopcock (QIT014)

- Pathway: 510(k) (Traditional)
- Applicant: Medex
- Decided: Apr 29, 2025 after 272 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862691 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold, Elcam Medical Acal (2013) Summary page 5.

## Indications for use
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient’s vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.

Source page: https://510kreport.com/device/K242255
Methodology: https://510kreport.com/methodology