# K090113: Breas Vivo 40 System

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: May 14, 2009 after 113 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- 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: 5 generations back to K971260 (1997). 18 ancestors in all.
23 later devices descend from it; 2 cite it directly.
5 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071702: Breas Vivo Bilevel System, Model Vivo 40, Breas Medical AB (2008) Summary page 1.
- K070328: Bipap Synchrony with Avaps, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.

## Most influential descendants
- K103167: Stellar 150 (2011), 20 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K113288: Vpap ST-a (2012), 7 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own

## Indications for use
The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The Vivo 40 is not intended to provide the total ventilatory requirements of the patient. The Vivo 40 is intended to be used for both invasive and non-invasive applications. The Vivo 40 is intended to be operated by qualified and trained personnel. The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Vivo 40 must always be prescribed by a licensed physician.

Source page: https://510kreport.com/device/K090113
Methodology: https://510kreport.com/methodology