# K071702: Breas Vivo Bilevel System, Model Vivo 40

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: Feb 15, 2008 after 239 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: 4 generations back to K971260 (1997). 9 ancestors in all.
24 later devices descend from it; 1 cites it directly.
5 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053607: Breas Vivo 40 System, Breas Medical AB (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K982545: BMP Cable System, Biomet, Inc. (1998). Our reading of the summary gave K982545, FDA’s number for BMP Cable System (Biomet, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Respironics Vision”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K090113: Breas Vivo 40 System (2009), 23 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K071702
Methodology: https://510kreport.com/methodology