# K980642: EVITA 4 (8411900)

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Sep 4, 1998 after 197 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
No predicates in its family tree.
112 later devices descend from it; 7 cite it directly.
32 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Evita 4: named in the summary without a submission number
- (no number) Evita 2 dura: named in the summary without a submission number
- (no number) Servo 300: named in the summary without a submission number

## Most influential descendants
- K022132: Servo Ventilator System, Model 64 87 800 E407E (2002), 102 descendants of its own
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), 75 descendants of its own
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own

## Indications for use
Evita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg. Intended Environment for the device: - hospital use - inner clinical transportt

Source page: https://510kreport.com/device/K980642
Methodology: https://510kreport.com/methodology