# K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Mar 19, 2019 after 427 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: 13 generations back to K902859 (1991). 64 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K151814: SERVO-U Ventilator System, SERVO-n Ventilator System, Maquet Critical Care AB (2015) Summary page 4.

## Most influential descendants
- 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/K180098
Methodology: https://510kreport.com/methodology