# K192611: Cuffix

- Pathway: 510(k) (Traditional)
- Applicant: Biovo Technologies, Ltd.
- Decided: Aug 13, 2020 after 328 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122721: AG Guffill, Hospitech Respiration, Ltd. (2013) Summary page 4.
- K833327: Respironics PR Valve, Respironics, Inc. (1983) Summary page 4.

## Indications for use
The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

Source page: https://510kreport.com/device/K192611
Methodology: https://510kreport.com/methodology