# K223499: Three Way Stop Cock

- Pathway: 510(k) (Traditional)
- Applicant: M/S Romsons International
- Decided: Jul 21, 2023 after 242 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: 3 generations back to K862691 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141254: Elcam Stopcocks and Manifolds, Elcam Medical Acal (2014) Summary page 4.

## Indications for use
3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions, intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.

Source page: https://510kreport.com/device/K223499
Methodology: https://510kreport.com/methodology