# K123149: Servo-I Ventilator System

- Pathway: 510(k) (Abbreviated)
- Applicant: Maquet Critical Care AB
- Decided: Jun 20, 2014 after 623 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K902859 (1991). 62 ancestors in all.
9 later devices descend from it; 3 cite it directly.
8 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585, Maquet Critical Care AB (2008) Summary page 1.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.

## Most influential descendants
- K151814: SERVO-U Ventilator System, SERVO-n Ventilator System (2015), 4 descendants of its own
- K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (2019), 3 descendants of its own
- K153688: Edi Catheter ENFit (2017), 1 descendant of its own
- K142679: Carescape R860 (2015), 1 descendant of its own
- K253715: Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) (2026), 0 descendants of its own

## Recalls of this device
- Sep 17, 2020 · Class II · Z-0092-2021: A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
- Jan 12, 2015 · Class II · Z-1224-2015: A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.

## 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 added indications for use of the NAVA option is when the electrical signal from the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube. The SERVO-i Ventilator is classified as MR Conditional for I .T. I.5T and 3T MR scanner. This means that ir is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met. 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/K123149
Methodology: https://510kreport.com/methodology