# K983219: Neoflow Option Model Numbers 8413563, 8411900

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Dec 7, 1998 after 84 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.
53 later devices descend from it; 6 cite it directly.
19 of 54 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) Babylog 8000 plus: named in the summary without a submission number
- (no number) Servo 300: named in the summary without a submission number

## Most influential descendants
- K051263: Evitaxl with Option Smartcare (2005), 51 descendants of its own
- K061090: Galileo Gold Asv (2006), 36 descendants of its own
- K070513: Hamilton-G5 (2007), 26 descendants of its own
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 (2008), 23 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own

## Indications for use
The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg. The device is microprocessor controlled and provides the following ventilation modes: - CMVl/assist Controlled Mandatory Ventiiation Controlled and assisted volume constant ventilation, with the options: - CPPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation - SiMV Synchronised Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow - MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow - SB Spontaneous Breathing Spontaneous breathing at ambient pressure - CPAP Continuos Positive Airway Pressure Spontaneous breathing with positive airway pressure - ASBIPSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spantaneous breathing - PCV+ Pressure controlled ventilation, combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level - APRV Alrway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable. - Apnea Ventilation For switching over automatically to volume controlled ventilation if breathing stops. - Independent Lung Ventilation Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each

Source page: https://510kreport.com/device/K983219
Methodology: https://510kreport.com/methodology