# K152778: TRACOE Cuff Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Dec 21, 2016 after 453 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 K951046 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951046: Rusch Endotest Cuff Pressure Monitor, Rusch Intl. (1995) Summary page 4.

## Indications for use
The TRACOE® cuff pressure monitor (cpm) is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes. Patient Population: Adult, pediatric, neonatal patients who have high-volume-low-pressure cuffed endotracheal/tracheostomy tubes.

Source page: https://510kreport.com/device/K152778
Methodology: https://510kreport.com/methodology