# K083050: Evite XL

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Dec 29, 2008 after 76 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). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474, Drager Medizintechnik GmbH (2001) Summary page 2.
- K980642: EVITA 4 (8411900), Drager, Inc. (1998) Summary page 2.
- K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 2.

## Most influential descendants
- K220107: Mindray SV600 Ventilator, Mindray SV800 Ventilator (2023), 1 descendant of its own
- K243767: SV600, SV800 Ventilator (2025), 0 descendants of its own

## Indications for use
Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.

Source page: https://510kreport.com/device/K083050
Methodology: https://510kreport.com/methodology