# K982128: Shikani-French Speaking Valve

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Surgical
- Decided: Oct 23, 1998 after 128 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: 3 generations back to K934465 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944451: Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves), Passy-Muir, Inc. (1995) Summary page 2.
- K964056: Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile, Rusch Intl. (1997) Summary page 2.
- (no number) A&M speaking valve: named in the summary without a submission number

## Most influential descendants
- K100995: Shikani Speaking Valve (2010), 0 descendants of its own

## Indications for use
To allow airflow over the vocal cords for speaking function. To be used only as an attachment to CLJackson improved trachea tubes, manufactured by Pilling Weck Surgical.

Source page: https://510kreport.com/device/K982128
Methodology: https://510kreport.com/methodology