# K243562: CuffGuard

- Pathway: 510(k) (Traditional)
- Applicant: Idmed
- Decided: Aug 12, 2025 after 267 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.
No later device cites it as a predicate yet.
0 of 8 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 5.

## Indications for use
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.

Source page: https://510kreport.com/device/K243562
Methodology: https://510kreport.com/methodology