# K151814: SERVO-U Ventilator System, SERVO-n Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Dec 21, 2015 after 168 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: 12 generations back to K902859 (1991). 63 ancestors in all.
4 later devices descend from it; 1 cites it directly.
7 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123149: Servo-I Ventilator System, Maquet Critical Care AB (2014) Summary page 4.

## Most influential descendants
- K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (2019), 3 descendants of its own
- K243767: SV600, SV800 Ventilator (2025), 0 descendants of its own
- K201874: Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 (2021), 0 descendants of its own
- K192604: Servo-air 4.0 Ventilator System (2020), 0 descendants of its own

## 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 For NAVA and Edi monitoring, it is in addition intended: to provide monitoring of the patient's breathing drive to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active for use on all patients with no contraindication for insertion/exchange of a nasogastric tube 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 For NAVA and Edi monitoring, it is in addition intended: to provide monitoring of the patient's breathing drive to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

Source page: https://510kreport.com/device/K151814
Methodology: https://510kreport.com/methodology