# K163127: bellavista 1000

- Pathway: 510(k) (Traditional)
- Applicant: Imtmedical AG
- Decided: Jul 31, 2017 after 265 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K183364: Bellavista (2019), 0 descendants of its own

## Recalls of this device
- Nov 25, 2019 · Class II · Z-1439-2020: The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.

Source page: https://510kreport.com/device/K163127
Methodology: https://510kreport.com/methodology