# K240919: Silk Voice (SMI-04)

- Pathway: 510(k) (Special)
- Applicant: Sofregen Medical
- Decided: May 3, 2024 after 30 days
- Product code: MIX (System, Vocal Cord Medialization)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913882 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180631: Silk Voice, Sofregen Medical, Inc. (2018) Summary page 4.

## Indications for use
Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Source page: https://510kreport.com/device/K240919
Methodology: https://510kreport.com/methodology