# K122721: AG Guffill

- Pathway: 510(k) (Traditional)
- Applicant: Hospitech Respiration, Ltd.
- Decided: May 3, 2013 after 240 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: 3 generations back to K912723 (1991). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 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 2.
- K081805: Cuffalert, Sunmed (2008) Summary page 2.
- K102704: Easy Cuff, Joan Spiegel, MD (2011) Summary page 2.
- K092733: PYTON, Arm Medical Devices, Inc. (2010) Summary page 2.

## Most influential descendants
- K242642: CuffTrek (2025), 0 descendants of its own
- K192611: Cuffix (2020), 0 descendants of its own

## Indications for use
The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The Hospitech AG Cuffill is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.

Source page: https://510kreport.com/device/K122721
Methodology: https://510kreport.com/methodology