# K961982: Tri-Flow Three Way Stopcock

- Pathway: 510(k) (Traditional)
- Applicant: North, Inc.
- Decided: Feb 21, 1997 after 277 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medex, Inc. 3-Way stopcock: named in the summary without a submission number
- (no number) North American Instrument Corporation stopcock: named in the summary without a submission number
- (no number) Tronomed/Mallinckrodt stopcock: named in the summary without a submission number

## Indications for use
Similar in intended use to the selected legally marketed devices, the Tri-Flow™ 3-Way Stopcock is designed to be used in any medical procedure where controlled flow of fluid is required. It is specifically designed to be used in procedures where three different fluids are administered into one line.

Source page: https://510kreport.com/device/K961982
Methodology: https://510kreport.com/methodology