# K202874: Puritan Bennett Cuff Pressure Manager

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jan 9, 2021 after 103 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912723 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150893: IntelliCuff, Hamilton Medical AG (2016) Summary page 5.

## Recalls of this device
- Aug 22, 2023 · Class II · Z-2651-2023: Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevent

## Indications for use
The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas: Intensive care unit (ICU) Recovery room Emergency medical care Medical emergency vehicles when the patient is being transported During transport within and outside of the hospital

Source page: https://510kreport.com/device/K202874
Methodology: https://510kreport.com/methodology