# K172266: Dynarex Three-Way Stopcock

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corporation
- Decided: Mar 14, 2018 after 230 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: 4 generations back to K862691 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111016: Safeport Manifold (TM) (or Stopcock), Elcam Medical Acal (2011) Summary page 4.

## Indications for use
The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).

Source page: https://510kreport.com/device/K172266
Methodology: https://510kreport.com/methodology