# K121886: Savina 300 Savina 300, Country Variants

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical GmbH
- Decided: Aug 8, 2014 after 771 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: 8 generations back to K962603 (1997). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003068: Savina, Drager Medizintechnik GmbH (2001) Summary page 8.
- K093633: Infinity Acute Care System Workstation Critical Care, Draegerwerk AG & CO Kgaa (2010) Summary page 8.
- K103625: Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device, Draeger Medical Systems, Inc. (2011) Summary page 8.

## Most influential descendants
- K180779: Savina 300 (2019), 0 descendants of its own

## Indications for use
Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (11Ibs) bodyweight. 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, recovery rooms and generally for hospital use - During the transport of ventilated patients within the hospital - During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300) - During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

Source page: https://510kreport.com/device/K121886
Methodology: https://510kreport.com/methodology