# K024213: Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910 E392E, 65 22 572 E397E, 65 03 655

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 23, 2004 after 459 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902859 (1991). 19 ancestors in all.
5 later devices descend from it; 1 cites it directly.
3 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973971: Kion Anesthesia System, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K001315: Modification to Kion Anesthesia System, Siemens Elema AB (2000) Summary page 1.
- K010923: Kion Anaesthesia System, Model 65 03 879 E392E, Siemens Elema AB (2002) Summary page 1.
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 1.
- K811102: Siemens-Elema AB Servo Ventilator 900 C, Siemens Elema AB (1981) Summary page 1.
- K893786: Servo Anesthesia Circle 985, Siemens Life Support Systems (1989) Summary page 1.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 2.

## Most influential descendants
- 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
- K160665: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (2017), 1 descendant of its own
- K191027: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (2020), 0 descendants of its own

## Recalls of this device
- Jan 11, 2005 · Not classified · Z-0710-05: Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

## Indications for use
Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.

Source page: https://510kreport.com/device/K024213
Methodology: https://510kreport.com/methodology