# K123511: S9 Vpap TX

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Mar 21, 2013 after 128 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). 103 ancestors in all.
1 later device descends from it; 1 cites 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 1.
- K102513: S9 Vpap ST with H5I, Resmed, Ltd. (2011) Summary page 2.
- K113801: Vpap Adapt, Resmed Corp (2012) Summary page 1.
- K091947: S8 Aspen with H4I Plus, Resmed, Ltd. (2009) Summary page 1.

## Most influential descendants
- K161487: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (2016), 0 descendants of its own

## Indications for use
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 30 lb (13 kg); all other modes are indicated for patients weighing more than 66 lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment

Source page: https://510kreport.com/device/K123511
Methodology: https://510kreport.com/methodology