# K113640: Stellar 150

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Apr 5, 2012 after 118 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: 9 generations back to K902859 (1991). 79 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103167: Stellar 150, Resmed Germany, Inc. (2011) Summary page 1.

## Most influential descendants
- K122715: Stellar 150 (2013), 0 descendants of its own

## Indications for use
The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

Source page: https://510kreport.com/device/K113640
Methodology: https://510kreport.com/methodology