# K153061: Juno VPAP ST-A

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Apr 13, 2016 after 175 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: 10 generations back to K971260 (1997). 101 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113288: Vpap ST-a, Resmed, Ltd. (2012) Summary page 4.

## Most influential descendants
- K161492: Juno VPAP ST-A (2017), 1 descendant of its own
- K251661: Mariana Minerva; Mariana Nimbus (2026), 0 descendants of its own
- K213169: BPAP System (2022), 0 descendants of its own

## Indications for use
The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The Juno VPAP ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

Source page: https://510kreport.com/device/K153061
Methodology: https://510kreport.com/methodology
