# K161487: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Sep 9, 2016 after 101 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: 11 generations back to K971260 (1997). 104 ancestors in all.
No later device cites it as a predicate yet.
3 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051364: Vpap Adapt, Resmed, Ltd. (2005) Summary page 6.
- K092186: Vpap TX, Resmed, Ltd. (2009) Summary page 9.
- K123511: S9 Vpap TX, Resmed, Ltd. (2013) Summary page 12.

## Indications for use
The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment. The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

Source page: https://510kreport.com/device/K161487
Methodology: https://510kreport.com/methodology