# K210516: Clicky Cross

- Pathway: 510(k) (Traditional)
- Applicant: Yomura Technologies, Inc.
- Decided: May 16, 2022 after 447 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
Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

Source page: https://510kreport.com/device/K210516
Methodology: https://510kreport.com/methodology