# K251661: Mariana Minerva; Mariana Nimbus

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Pty, Ltd.
- Decided: Feb 23, 2026 after 269 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- 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: 12 generations back to K971260 (1997). 103 ancestors in all.
No later device cites it as a predicate yet.
3 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161492: Juno VPAP ST-A, Resmed, Ltd. (2017) Summary page 5.

## Indications for use
The Mariana Minerva is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use. The Mariana Nimbus is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.

Source page: https://510kreport.com/device/K251661
Methodology: https://510kreport.com/methodology