# K130245: Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 1, 2013 after 29 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961225 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962581: Stopcock Manifold Gangs, Baxter Healthcare Corp (1996) Summary page 2.
- K961225: Continuflo Solution Set/Secondary Medication Set, Baxter Healthcare Corp (1996) Summary page 2.

## Most influential descendants
- K223175: lntravascular Administration Sets with Stopcock and Manifold (2023), 0 descendants of its own

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0189-2026: IV sets may leak.

## Indications for use
To administer fluids from a container into the patient's vascular system through a vascular access device.

Source page: https://510kreport.com/device/K130245
Methodology: https://510kreport.com/methodology