# K043160: Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/SO

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Feb 18, 2005 after 95 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; 1 cites 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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

## Indications for use
The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with and without a supplementary oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the outer aspect of a tracheostomy tube with a 15mm standard connector (Phon Assist I- Model 650-T/TO) or a Tracoe Stoma Button (Phon Assist I- Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane which allows air to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth. The Phon Assist I (Ref Model 650-T/TO) Speaking Valves are indicated for uncuffed tracheostomy patients, cuffed tubes that have been fenestrated or deflated and Tracoe Stoma Buttons (Ref Model 650-S/SO) in the cases of: Mild Tracheal Stenosis Laryngeal Tumors Bilateral Vocal Cord Paralysis Trachealmalacia Head Trauma Broncheopulmonary Dysplasia Amyotrophic Lateral Sclerosis Chronic Obstructive Pulmonary Disease

Source page: https://510kreport.com/device/K043160
Methodology: https://510kreport.com/methodology