# K970165: Evita 2 Dura

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Aug 26, 1997 after 222 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 K902859 (1991). 4 ancestors in all.
140 later devices descend from it; 5 cite it directly.
44 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 2.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 2.
- (no number) Servo 300: named in the summary without a submission number

## Most influential descendants
- K041775: GE Datex-Ohmeda Engstrom Carestation (2004), 107 descendants of its own
- K051767: LTV 1000 Ventilator (2005), 57 descendants of its own
- K022679: Raphael (2003), 54 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own
- K021573: Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option (2002), 52 descendants of its own

## Indications for use
Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg. The device is microprocessor-controlled and provides the following ventilation modes: -CMV Intermittent Positive Pressure Ventilation Controlled and assisted volume-constant ventilation - SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing - MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient’s minute volume requirement. - CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure and adjustable pressure support. - PCV+ Presure Controlled Ventilation Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level. - APRV Airway Pressure Release Ventilation Spontaneoous breathing on two pressure levels with long time ranges - independently adjustable. Furthermore Evita 2 dura offers the following special ventilation modes: - Apnea ventilation For switching over automatically to volume-controlled ventilation if breathing stops. -ILV Independent Lung Ventilation, optional Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung. Application range - Intensive care units - Inner-clinical transport

Source page: https://510kreport.com/device/K970165
Methodology: https://510kreport.com/methodology