# K253647: Evita (V800); Evita (V600)

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: May 7, 2026 after 168 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- 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: 2 generations back to K093633 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222024: Evita V800, Evita V600, Draegerwerk AG & CO Kgaa (2023) Summary page 5.

## Indications for use
The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.

Source page: https://510kreport.com/device/K253647
Methodology: https://510kreport.com/methodology