# K152865: TRACOE smart Cuff Manager

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Sep 27, 2016 after 363 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 K791045 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833327: Respironics PR Valve, Respironics, Inc. (1983) Summary page 4.
- K791045: Model GV-10 Lanz Pressure-Valve, Extracorporeal Medical Specialities, Inc. (1979) Summary page 4.

## Indications for use
The TRACOE® smart Cuff Manager is intended to maintain the HVLP (high volume low pressure) cuff pressure, of an endotracheal tube or tracheostomy tube, within the range of 20 to 30 cm H20 through passive control. It is for single patient use, and indicated for mechanically ventilated or spontaneously breathing patients. It is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.

Source page: https://510kreport.com/device/K152865
Methodology: https://510kreport.com/methodology