# K160822: S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Sep 9, 2016 after 169 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102586: S9 Vpap Adapt with H5I, Resmed, Ltd. (2011) Summary page 6.
- K113801: Vpap Adapt, Resmed Corp (2012) Summary page 10.
- K140279: S9 Greenhills, Resmed, Ltd. (2014) Summary page 14.

## Indications for use
The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 Ib (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use. The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 1b (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It 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. The VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.

Source page: https://510kreport.com/device/K160822
Methodology: https://510kreport.com/methodology