# K012691: Monsoon Critical Care Jet Ventilator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Acutronic Medical Systems AG
- Decided: Dec 20, 2002 after 493 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 K863154 (1987). 2 ancestors in all.
50 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863155: Universal Jet Ventilator Model Ams-1000, Acutronic Medical Systems AG (1987) Summary page 1.
- K863154: Heated Jet Humidifier Model Ams-1020, Acutronic Medical Systems AG (1987) Summary page 1.

## Most influential descendants
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0 (2012), 49 descendants of its own
- K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software (2012), 45 descendants of its own
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw (2014), 40 descendants of its own
- K141518: Nellcor Bedside Respiratory Patient Monitoring System (2015), 29 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own

## Indications for use
The Monsoon Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy in a hospital or other clinical setting.

Source page: https://510kreport.com/device/K012691
Methodology: https://510kreport.com/methodology