# K223175: lntravascular Administration Sets with Stopcock and Manifold

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 10, 2023 after 150 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: 2 generations back to K961225 (1996). 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)
- K130245: Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo, Baxter Healthcare Corp (2013) Summary page 4.

## Indications for use
For the administration of fluids from a container into the patient's vascular system through a vascular access device.

Source page: https://510kreport.com/device/K223175
Methodology: https://510kreport.com/methodology