# K022132: Servo Ventilator System, Model 64 87 800 E407E

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 19, 2002 after 80 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: 2 generations back to K962517 (1997). 8 ancestors in all.
102 later devices descend from it; 6 cite it directly.
33 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010925: Servoi Ventilator System, Model 64 87 800 E407E, Siemens Elema AB (2001) Summary page 2.
- K001646: Puritan-Bennett 840 Ventilator System with Neomode Option, Puritan Bennett Corp. (2000)
- K980642: EVITA 4 (8411900), Drager, Inc. (1998) Summary page 1.
- K003068: Savina, Drager Medizintechnik GmbH (2001) Summary page 3.
- K001686: Galileo Ventilator, Hamilton Medical, Inc. (2000)
- K984407: Bipap Harmony S/T, Model 1001445, Respironics, Inc. (1999) Summary page 1.
- K003075: Knightstar 330 Ventilator, Mallinckrodt, Inc. (2001) Summary page 3.

## Most influential descendants
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), 75 descendants of its own
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own
- K051263: Evitaxl with Option Smartcare (2005), 51 descendants of its own

## Indications for use
The Servo' Ventilator System is intended for treatn ?nt and monitoring ofpatients in th range of neonates, infants and adults with respiratory failure or respiratory insuficiency. Servo' is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

Source page: https://510kreport.com/device/K022132
Methodology: https://510kreport.com/methodology