# K100995: Shikani Speaking Valve

- Pathway: 510(k) (Traditional)
- Applicant: Shikani Medical, LLC
- Decided: Jun 25, 2010 after 77 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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 K934465 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982128: Shikani-French Speaking Valve, Pilling Weck Surgical (1998) Summary page 1.

## Indications for use
To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.

Source page: https://510kreport.com/device/K100995
Methodology: https://510kreport.com/methodology