# K261499: TrachFlush

- Pathway: 510(k) (Traditional)
- Applicant: Aw Technologies Aps
- Decided: Aug 13, 2026 after 99 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K912723 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220854: TrachCuff Cuff Controller, Aw Technologies Aps (2023) Summary page 5.

## Indications for use
The TrachFlush device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The TrachFlush device is also intended to assist in clearing upper airway secretions by simulating an artificial cough during mechanical ventilation. The TrachFlush device can be used with any mechanical ventilator. The TrachFlush device is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas: • In the intensive care ward by Respiratory Therapist

Source page: https://510kreport.com/device/K261499
Methodology: https://510kreport.com/methodology