# K230173: Servo-air Lite Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Jul 6, 2023 after 167 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- 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: 6 generations back to K833786 (1983). 19 ancestors in all.
No later device cites it as a predicate yet.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102985: V60 Ventilator with PPV and Auto-Trak+ Software Options, Respironics, Inc. (2011) Summary page 5.

## Indications for use
Servo-air Lite Ventilator System is an assist ventilator indicated for augmenting ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers non-invasive ventilation, invasive ventilation, and respiratory monitoring. Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above. Servo-air Lite Ventilator System is to be used only by healthcare professionals. Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.

Source page: https://510kreport.com/device/K230173
Methodology: https://510kreport.com/methodology