# K992608: Atc Option for Evita 2 Dura and Evita 4

- Pathway: 510(k) (Special)
- Applicant: Drager, Inc.
- Decided: Aug 24, 1999 after 20 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.
133 later devices descend from it; 5 cite it directly.
42 of 134 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 2 dura: named in the summary without a submission number
- (no number) Evita 4: 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
- K040574: Galileo Gold (2004), 53 descendants of its own
- K051263: Evitaxl with Option Smartcare (2005), 51 descendants of its own
- K051895: GE Datex-Ohmeda Engstrom Carestation (2005), 49 descendants of its own

## Indications for use
The Evita 2 dura and the Evita 4 are time cycled , constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg. intended environment for use of the device - user facilities - inner clinical transport

Source page: https://510kreport.com/device/K992608
Methodology: https://510kreport.com/methodology