# K103167: Stellar 150

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Mar 1, 2011 after 125 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: 8 generations back to K902859 (1991). 78 ancestors in all.
20 later devices descend from it; 4 cite it directly.
8 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090113: Breas Vivo 40 System, Breas Medical AB (2009) Summary page 1.
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.
- K060705: Carina Home, Draeger Medical B.V. (2006) Summary page 1.

## Most influential descendants
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K113288: Vpap ST-a (2012), 7 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K153061: Juno VPAP ST-A (2016), 3 descendants of its own

## Indications for use
The Stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13kg 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 an uncuffed or deflated tracheostomy. 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/K103167
Methodology: https://510kreport.com/methodology
