# K183364: Bellavista

- Pathway: 510(k) (Traditional)
- Applicant: Imtmedical AG
- Decided: Sep 13, 2019 after 283 days
- Product code: CBK (Ventilator, Continuous, Facility 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: 1 generation back to K163127 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163127: bellavista 1000, Imtmedical AG (2017) Summary page 4.

## Recalls of this device
- May 5, 2023 · Class II · Z-1966-2023: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the devic
- May 5, 2023 · Class II · Z-1967-2023: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the devic
- Dec 20, 2021 · Class I · Z-0622-2022: Potential cessation in ventilation can occur under specific conditions.

## Indications for use
The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician. Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

Source page: https://510kreport.com/device/K183364
Methodology: https://510kreport.com/methodology