# K122715: Stellar 150

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Jun 17, 2013 after 285 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K902859 (1991). 103 ancestors in all.
No later device cites it as a predicate yet.
9 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113640: Stellar 150, Resmed Germany, Inc. (2012) Summary page 1.
- K111610: Trilogy Series Ventilator with Oximetry, Respironics, Inc. (2011) Summary page 1.

## Recalls of this device
- Dec 12, 2019 · Class I · Z-0915-2020: Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are store

## 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/K122715
Methodology: https://510kreport.com/methodology