# K122932: Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen Port

- Pathway: 510(k) (Traditional)
- Applicant: Fogless International AB
- Decided: Dec 23, 2013 after 455 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151404: ProTrach Dualcare (2016), 0 descendants of its own

## Indications for use
One way Speaking Valve for spontaneous breathing tracheotomy patients. The device connects directly to an ISO 15mm tracheostomy tube. The valve opens upon inhalation and then closes immediately upon exhalation, forcing the expired gases through the larynx and mouth to produce speech.

Source page: https://510kreport.com/device/K122932
Methodology: https://510kreport.com/methodology