# K944451: Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves)

- Pathway: 510(k) (Traditional)
- Applicant: Passy-Muir, Inc.
- Decided: Jul 7, 1995 after 298 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982128: Shikani-French Speaking Valve (1998), 1 descendant of its own
- K100995: Shikani Speaking Valve (2010), 0 descendants of its own
- K013728: Trach Vox (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K944451
Methodology: https://510kreport.com/methodology