# K113288: Vpap ST-a

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Mar 29, 2012 after 143 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: 9 generations back to K971260 (1997). 100 ancestors in all.
7 later devices descend from it; 3 cite it directly.
3 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102513: S9 Vpap ST with H5I, Resmed, Ltd. (2011) Summary page 1.
- K103167: Stellar 150, Resmed Germany, Inc. (2011) Summary page 1.
- K033276: Vpap Iii ST-a, Resmed, Ltd. (2004) Summary page 1.

## Most influential descendants
- K153061: Juno VPAP ST-A (2016), 3 descendants of its own
- K161492: Juno VPAP ST-A (2017), 1 descendant of its own
- K123511: S9 Vpap TX (2013), 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 VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

Source page: https://510kreport.com/device/K113288
Methodology: https://510kreport.com/methodology