# K203126: S10 Kirra

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Pty, Ltd.
- Decided: Dec 18, 2020 after 60 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). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140279: S9 Greenhills, Resmed, Ltd. (2014) Summary page 4.
- K140159: S9 Wanda Vpap ST, Resmed, Ltd. (2014) Summary page 4.
- K140124: S9 Elouera, Resmed Corp (2014) Summary page 4.

## Indications for use
The S10 Kirra is indicated to provide CPAP and Bi-level therapy 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). ASV and ASVAuto modes are also indicated for the treatment of central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

Source page: https://510kreport.com/device/K203126
Methodology: https://510kreport.com/methodology