# K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Jun 9, 2008 after 209 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: 10 generations back to K902859 (1991). 61 ancestors in all.
28 later devices descend from it; 4 cite it directly.
18 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063404: Servo-I Ventilator System, Models 64, 87 and 800, Maquet Critical Care AB (2007) Summary page 1.
- K022674: Bird Avea Ventilator, Bird Products Corp. (2002) Summary page 1.
- K041524: GE Datex-Ohmeda Heliox Delivery System, Datex-Ohmeda, Inc. (2004) Summary page 1.

## Most influential descendants
- K131774: Hamilton-G5 (2013), 10 descendants of its own
- K123149: Servo-I Ventilator System (2014), 9 descendants of its own
- K083693: PB 840 Ventilator System  with Leak Compensation Option, Model 840 (2009), 6 descendants of its own
- K103211: Avea Ventilator (2011), 5 descendants of its own
- K151814: SERVO-U Ventilator System, SERVO-n Ventilator System (2015), 4 descendants of its own

## Indications for use
The SERVO-i Ventilator System with Heliox option 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. The SERVO-i Ventilator System with Heliox option is also MR conditional. The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).

Source page: https://510kreport.com/device/K073179
Methodology: https://510kreport.com/methodology