# K884520: Servo Ventilator 900E

- Pathway: 510(k) (Traditional)
- Applicant: Siemens-Elema Ventilation Systems
- Decided: Jan 17, 1989 after 82 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 17, 2009 · Not classified · Z-0589-2010: Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damag

Source page: https://510kreport.com/device/K884520
Methodology: https://510kreport.com/methodology