# K945406: SSV Phonate (TM) Shiley Speaking Valve

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical Tpi, Inc.
- Decided: Feb 27, 1995 after 116 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K961449: Tracheostomy Tubes Tracoe-Flex (1996), 3 descendants of its own
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K945406
Methodology: https://510kreport.com/methodology