# K140124: S9 Elouera

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: May 12, 2014 after 116 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: 8 generations back to K913396 (1992). 48 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091947: S8 Aspen with H4I Plus, Resmed, Ltd. (2009) Summary page 1.
- K083575: Apnealink Plus, Model: 22328, Resmed Germany, Inc. (2009) Summary page 1.

## Most influential descendants
- K160836: Menai System (2016), 6 descendants of its own
- K200565: Galapogos (2021), 3 descendants of its own
- K241216: myAir (2024), 2 descendants of its own
- K250624: myAir (2025), 1 descendant of its own
- K252338: MySleepDash (2026), 0 descendants of its own

## Indications for use
The S9 Elouera self-adjusting device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use.

Source page: https://510kreport.com/device/K140124
Methodology: https://510kreport.com/methodology