# K122324: Vpap S-a

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Nov 13, 2012 after 104 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.
No later device cites it as a predicate yet.
3 of 102 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 1.

## Indications for use
The VPAP S-A is indicated to provide noninvasive ventilation for patients weighing more than 30 lbs (13 kg) with respiratory insufficiency such as that associated with hypercapnic Chronic Obstructive Pulmonary Disease (COPO) or obstructive sleep apnea (OSA). The VPAP S-A is intended for home and hospital use.

Source page: https://510kreport.com/device/K122324
Methodology: https://510kreport.com/methodology