# K973971: Kion Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 13, 1999 after 696 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902859 (1991). 14 ancestors in all.
6 later devices descend from it; 1 cites it directly.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841529: Siemens-Elema Ventilator 900C, Siemens Elema AB (1984) Summary page 2.
- K871354: Servo Ventilator 900 C/D, Siemens Elema AB (1987) Summary page 2.
- K861707: Master Program Flow & Pressure CO2 & Lung Monitor, Siemens Elema AB (1986) Summary page 2.
- K852771: PC Interface, Siemens Elema AB (1985) Summary page 2.
- K923444: Servo Graphics, Siemens Medical Solutions USA, Inc. (1993) Summary page 2.
- K854036: Manual Ventilation Accessory, Siemens Elema AB (1985) Summary page 2.
- K890932: Cav 3.0C Software Program, Siemens Life Support Systems (1989) Summary page 2.
- K893786: Servo Anesthesia Circle 985, Siemens Life Support Systems (1989) Summary page 2.
- K841157: Halothane Vaporizer 950, Enflurane, Siemens Elema AB (1984) Summary page 2.
- K942091: Ohmeda Tec 5 Vaporizer for Use with Sevoflurane, Ohmeda Medical (1995) Summary page 2.
- K960010: Servo Ventilator 300 Computer Interface, Siemens Elema AB (1996) Summary page 2.
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.
- K960168: Siemens Servo Screen 390 and Servo Computer Module 990, Siemens Elema AB (1996) Summary page 3.

## Most influential descendants
- 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
- K160665: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (2017), 1 descendant of its own

## Indications for use
Use of the KION Anesthesia System is indicated for adult or infant populations 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 the patient. This device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability to breathe.

Source page: https://510kreport.com/device/K973971
Methodology: https://510kreport.com/methodology