# K902859: Servo Ventilator 300

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Life Support Systems
- Decided: Apr 26, 1991 after 301 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
235 later devices descend from it; 10 cite it directly.
63 of 236 devices 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.

## Most influential descendants
- K961687: EVITA 4 (1996), 211 descendants of its own
- K960010: Servo Ventilator 300 Computer Interface (1996), 178 descendants of its own
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840) (1998), 174 descendants of its own
- K970839: Servo Ventilator 300A (1997), 171 descendants of its own
- K974176: Babylog 8000 Plus (1998), 151 descendants of its own

## Recalls of this device
- Nov 17, 2009 · Not classified · Z-0588-2010: 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
- Mar 23, 2009 · Not classified · Z-1252-2009: The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
- Jan 3, 2005 · Not classified · Z-0571-05: Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

Source page: https://510kreport.com/device/K902859
Methodology: https://510kreport.com/methodology