# K102704: Easy Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Joan Spiegel, MD
- Decided: Mar 10, 2011 after 171 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: 2 generations back to K912723 (1991). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 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.
- K081805: Cuffalert, Sunmed (2008) Summary page 1.

## Most influential descendants
- K142103: Cuff Pilot, Sure Seal (2015), 3 descendants of its own
- K122721: AG Guffill (2013), 2 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K242642: CuffTrek (2025), 0 descendants of its own
- K192611: Cuffix (2020), 0 descendants of its own

## Indications for use
To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.

Source page: https://510kreport.com/device/K102704
Methodology: https://510kreport.com/methodology