# K192604: Servo-air 4.0 Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critica Care AB
- Decided: Jun 18, 2020 after 272 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (1 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
- Jul 21, 2022 · Class II · Z-1568-2022: Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a
- 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-air ventilator system is • intended for respiratory support, monitoring and treatment of 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

Source page: https://510kreport.com/device/K192604
Methodology: https://510kreport.com/methodology