# K081805: Cuffalert

- Pathway: 510(k) (Traditional)
- Applicant: Sunmed
- Decided: Nov 14, 2008 after 141 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: 1 generation back to K912723 (1991). 2 ancestors in all.
33 later devices descend from it; 3 cite it directly.
8 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912723: Posey Cufflator, Posey Co. (1991) Summary page 1.
- K951046: Rusch Endotest Cuff Pressure Monitor, Rusch Intl. (1995) Summary page 1.

## Most influential descendants
- K092733: PYTON (2010), 27 descendants of its own
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K131774: Hamilton-G5 (2013), 10 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K102704: Easy Cuff (2011), 7 descendants of its own

## Indications for use
To measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes. The CuffAlertTM is not intended to replacement clinical judgment. Patients who are intubated.

Source page: https://510kreport.com/device/K081805
Methodology: https://510kreport.com/methodology