# K013728: Trach Vox

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Jul 30, 2002 after 263 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: 1 generation back to K811241 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821568: Blow-Singer Tracheostoma Valve, Bivona Medical Technologies (1982) Summary page 1.
- K944451: Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves), Passy-Muir, Inc. (1995) Summary page 1.
- K952845: Humid-Vent Trach-Vent, Gibeck, Inc. (1995) Summary page 1.
- K914336: Breathe Easy, Vital Signs, Inc. (1992) Summary page 1.
- K811241: Bodai Suction -Safe 4, Sontek Industries, Inc. (1981) Summary page 1.
- (no number) Intersurgical - Hydro-Trach T: named in the summary without a submission number

## Indications for use
For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech. For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.

Source page: https://510kreport.com/device/K013728
Methodology: https://510kreport.com/methodology