# K242642: CuffTrek

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Longmann Tech Co., Ltd.
- Decided: Mar 7, 2025 after 185 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 5.

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

Source page: https://510kreport.com/device/K242642
Methodology: https://510kreport.com/methodology