# K102674: Cuff Sentry

- Pathway: 510(k) (Traditional)
- Applicant: Ventlab Corp.
- Decided: Jul 22, 2011 after 309 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ventlab Cuff Sentry Cuff Inflation Device is designed to measure and regulate intra-cuff pressures of endotracheal and tracheostomy tubes. This device is a single patient use, non-sterile prescription device that is indicated for patients in all age groups who are managed with inflatable air-filled cuffs. It is intended for' use in hospitals, pre-hospitals (EMS), extended care facilities and outpatient clinics.

Source page: https://510kreport.com/device/K102674
Methodology: https://510kreport.com/methodology