# K220854: TrachCuff Cuff Controller

- Pathway: 510(k) (Traditional)
- Applicant: Aw Technologies Aps
- Decided: Apr 14, 2023 after 387 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: 4 generations back to K912723 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150893: IntelliCuff, Hamilton Medical AG (2016) Summary page 4.

## Most influential descendants
- K261499: TrachFlush (2026), 0 descendants of its own

## Indications for use
The TrachCuff Cuff Controller 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 TrachCuff Cuff Controller can be used with any mechanical ventilator. The TrachCuff Cuff Controller 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/K220854
Methodology: https://510kreport.com/methodology