# K180779: Savina 300

- Pathway: 510(k) (Traditional)
- Applicant: Dragerwerk AG & CO Kgaa
- Decided: Jan 17, 2019 after 297 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: 9 generations back to K962603 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
4 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121886: Savina 300 Savina 300, Country Variants, Draeger Medical GmbH (2014) Summary page 5.
- K093633: Infinity Acute Care System Workstation Critical Care, Draegerwerk AG & CO Kgaa (2010) Summary page 5.

## Indications for use
The intensive care ventilator Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 1bs) body weight. Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: —In intensive care wards, in recovery rooms and generally for hospital use — During the transfer of ventilated patients within the hospital

Source page: https://510kreport.com/device/K180779
Methodology: https://510kreport.com/methodology