# K160481: Vivo 60

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: Nov 9, 2016 after 261 days
- Product code: NOU (Continuous, Ventilator, Home Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K902859 (1991). 87 ancestors in all.
7 later devices descend from it; 3 cite it directly.
11 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123144: VIVO 50, Ge Healthcare, Breas Medical AB (2013) Summary page 4.
- K133868: Astral Ventilator, Resmed, Ltd. (2014) Summary page 4.

## Most influential descendants
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own
- K233452: Vivo 45 LS (2025), 0 descendants of its own
- K241135: RESPOND (R) Ventilator (2024), 0 descendants of its own

## Recalls of this device
- Jan 28, 2020 · Class II · Z-1352-2020: The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
- May 8, 2018 · Class III · Z-2530-2018: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.

## Indications for use
The Vivo 60 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.) The Vivo 60 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The Vivo 60 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas. The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 60 is not intended to be used as a transport or critical care ventilator.

Source page: https://510kreport.com/device/K160481
Methodology: https://510kreport.com/methodology