# K062104: Talking Trach

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems, Inc.
- Decided: Apr 20, 2007 after 270 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
Longest line of descent: 2 generations back to K792222 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962714: Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valve; Product Number PMV 2000 or Pmtsv 2000, Passy-Muir, Inc. (1996) Summary page 1.
- K972385: Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed, Smiths Industries Medical Systems, Inc. (1998) Summary page 1.
- K962173: Shikey Tracheostomy Tubes and Accessories, Mallinckrodt Medical (1996) Summary page 1.

## Indications for use
The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.

Source page: https://510kreport.com/device/K062104
Methodology: https://510kreport.com/methodology