# K151404: ProTrach Dualcare

- Pathway: 510(k) (Traditional)
- Applicant: Atos Medical AB
- Decided: Feb 12, 2016 after 262 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 K122932 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122932: Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen Port, Fogless International AB (2013) Summary page 4.

## Indications for use
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech. The entire device is for single patient use and the HME-part is for single use. Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. Environment of Use: Hospitals, ICU, sub-acute care institutions and home.

Source page: https://510kreport.com/device/K151404
Methodology: https://510kreport.com/methodology