# K960168: Siemens Servo Screen 390 and Servo Computer Module 990

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Elema AB
- Decided: Oct 25, 1996 after 283 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
3 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LEONARDO Patient Data Manager: named in the summary without a submission number
- (no number) 7202 Display Option Module: named in the summary without a submission number
- (no number) EVITA Ventilator: named in the summary without a submission number

## Most influential descendants
- K973971: Kion Anesthesia System (1999), 6 descendants of its own
- K024213: Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 (2004), 5 descendants of its own
- K102182: Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 (2011), 4 descendants of its own
- K112114: Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40 (2012), 3 descendants of its own
- K133958: Flow-I Anesthesia System C20, C30 & C40 (2014), 2 descendants of its own

## Indications for use
The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory status of the patient. When review of the tabular or graphical data displayed on the Servo Ventilator 300 indicate that intervention may be required, it is the responsibility of the clinician to verify critical settings and measurements on the ventilator control panel and to obtain appropriate additional data from other sources before initiating changes in therapy. The Servo Screen 390 does not control the ventilator, nor does it recommend specific changes in therapy or provide a diagnosis. It is a device for the formatting and display of data.

Source page: https://510kreport.com/device/K960168
Methodology: https://510kreport.com/methodology