# K960010: Servo Ventilator 300 Computer Interface

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Elema AB
- Decided: Oct 25, 1996 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: 1 generation back to K902859 (1991). 1 ancestor in all.
178 later devices descend from it; 3 cite it directly.
49 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 2.

## Most influential descendants
- K970839: Servo Ventilator 300A (1997), 171 descendants of its own
- K993449: Bird V.I.P. Gold/Sterling (1999), 134 descendants of its own
- K992788: Bear Cub 750 PSV (1999), 134 descendants of its own
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own

## Indications for use
The Siemens Servo Ventilator 300 is intended for general and critical ventilatory care for use with neonatal, infant, pediatric, and adult patients The unit is designed to be used at the bedside and for in-hospital transport. It is not intended for transport use in ambulances or helicopters in the U.S. market. The intended use of the Computer Interface Board Version 2 is the same as for the Computer Interface Board Version 1. The CI board stores and transmits information about the ventilator to external digital devices via optically isolated serial interfaces.

Source page: https://510kreport.com/device/K960010
Methodology: https://510kreport.com/methodology