# K053607: Breas Vivo 40 System

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: Mar 16, 2006 after 79 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: 3 generations back to K971260 (1997). 8 ancestors in all.
25 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)
- K974539: Sullivan Vpap II ST Ventilatory Support System, Resmed, Ltd. (1998) Summary page 1.
- K003075: Knightstar 330 Ventilator, Mallinckrodt, Inc. (2001) Summary page 1.
- K030843: Vpap Iii, Resmed, Ltd. (2003) Summary page 1.
- K002454: Breas HA50 Humidifier, Model HA50, Vital Signs, Inc. (2001) 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
- K071702: Breas Vivo Bilevel System, Model Vivo 40 (2008), 24 descendants of its own
- 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

## Indications for use
The Breas Vivo 40 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/K053607
Methodology: https://510kreport.com/methodology