# K012693: Mistral Critical Care Jet Ventilator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Acutronic Medical Systems AG
- Decided: Aug 1, 2002 after 352 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: 1 generation back to K900745 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900745: VS-200S Jet Ventilator, Acutronic Medical Systems AG (1991) Summary page 1.

## Indications for use
The Mistral Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy for applications up to 45 minutes duration on adults in a hospital or other clinical setting.

Source page: https://510kreport.com/device/K012693
Methodology: https://510kreport.com/methodology