# K201874: Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Apr 20, 2021 after 287 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K902859 (1991). 65 ancestors in all.
No later device cites it as a predicate yet.
6 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1, Maquet Critical Care AB (2019) Summary page 5.

## Recalls of this device
- Jun 30, 2026 · Class II · Z-2963-2026: Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.
- May 30, 2025 · Class I · Z-2014-2025: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- May 30, 2025 · Class I · Z-2015-2025: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- May 30, 2025 · Class I · Z-2013-2025: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- Jul 20, 2022 · Class I · Z-1560-2022: Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue

## Indications for use
The Servo-u Ventilator System is: * intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients * to be used only by healthcare providers * to be used only in professional healthcare facilities and for transport within these facilities The Servo-n Ventilator System is: * intended for respiratory support, monitoring and treatment of neonatal and pediatric patients * to be used only by healthcare providers * to be used only in professional healthcare facilities and for transport within these facilities The Servo-u MR Ventilator System is: * intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients * to be used only by healthcare providers * to be used only in professional healthcare facilities and for transport within these facilities * to be used in MR environment according to specified conditions - with 1.5 T or 3 T MR scanners - outside magnetic fields >20 mT/200 Gauss

Source page: https://510kreport.com/device/K201874
Methodology: https://510kreport.com/methodology