# K063404: Servo-I Ventilator System, Models 64, 87 and 800

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Feb 15, 2007 after 98 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: 9 generations back to K902859 (1991). 57 ancestors in all.
61 later devices descend from it; 4 cite it directly.
30 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.
- K050055: GE Datex-Ohmeda Aestiva/5 Mri Anesthesia System, Datex-Ohmeda, Inc. (2005) Summary page 1.
- K896380: IC-2A Mri Adult/Pediatric Ventilator, Bio-Med Devices, Inc. (1990) Summary page 1.
- K896381: MVP-10 Mri Infant Ventilator, Bio-Med Devices, Inc. (1990). Our reading of the summary gave K896391, FDA’s number for Bard/Angiomed Stents (C.R. Bard, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MVP-110”.
- K061627: Modification to I Vent 201, Versamed Medical Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K093886: Engstrom Carestation, Engstrom Pro (2010), 21 descendants of its own
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K112722: GE Datex-Ohmeda Avance (2011), 13 descendants of its own

## 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 The SERVO-i Ventilator is classified as MR Conditional for 1.T, 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met,

Source page: https://510kreport.com/device/K063404
Methodology: https://510kreport.com/methodology