# K193586: Vivo 45 LS

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: Jan 27, 2021 after 401 days
- Product code: NOU (Continuous, Ventilator, Home Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K953930 (1996). 174 ancestors in all.
2 later devices descend from it; 2 cite it directly.
18 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160481: Vivo 60, Breas Medical AB (2016) Summary page 4.
- K181166: Trilogy Evo, Respironics, Inc. (2019) Summary page 4.

## Most influential descendants
- K232365: Vivo 45 LS (2025), 0 descendants of its own
- K233452: Vivo 45 LS (2025), 0 descendants of its own

## Recalls of this device
- Jul 25, 2024 · Class I · Z-2690-2024: There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
- Oct 13, 2023 · Class II · Z-0405-2024: Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
- Jun 2, 2022 · Class II · Z-1382-2022: A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health 

## Indications for use
The Vivo 45 LS ventilator (with or without the SpO2 and C02 sensors) 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.), however, the mouthpiece ventilation modes are for adult patients only. The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. The Vivo 45 LS with the C02 sensor is intended to measure C02 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 45 LS is not intended to be used as an emergency transport or critical care ventilator.

Source page: https://510kreport.com/device/K193586
Methodology: https://510kreport.com/methodology