# K254239: CyClean Cord

- Pathway: 510(k) (Traditional)
- Applicant: SS Global
- Decided: Mar 27, 2026 after 88 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- 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 K132526 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171577: Smartcord, Smartcord X, Eastdent Co., Ltd. (2018) Summary page 5.

## Indications for use
CyClean Cord is knitted retraction cord made from 100% lyocell, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.

Source page: https://510kreport.com/device/K254239
Methodology: https://510kreport.com/methodology