# K040221: Servo-I Ventilator System, Model 64 87 800 E407E

- Pathway: 510(k) (Special)
- Applicant: Maquet Critical Care AB
- Decided: Feb 20, 2004 after 18 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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). 12 ancestors in all.
75 later devices descend from it; 2 cite it directly.
29 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 1.
- K022132: Servo Ventilator System, Model 64 87 800 E407E, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K980642: EVITA 4 (8411900), Drager, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 (2008), 28 descendants of its own
- K070513: Hamilton-G5 (2007), 26 descendants of its own

## Recalls of this device
- Mar 24, 2005 · Not classified · Z-0878-05: Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will

## Indications for use
The Servo-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i 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/K040221
Methodology: https://510kreport.com/methodology