# K060546: Breas Vivo Bilevel System, Model Vivo 30

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: May 26, 2006 after 86 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K974417 (1998). 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)
- K974417: Sullivan Vpap II ST-a Nasal Vpap System, Resmed Corp (1998) Summary page 1.

## Indications for use
The Breas Vivo 30 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day.

Source page: https://510kreport.com/device/K060546
Methodology: https://510kreport.com/methodology