# K132606: S9 Cronulla for Her

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jan 13, 2014 after 146 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 K971260 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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.

## Indications for use
The S9 Cronulla for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg). The S9 Cronulla for Her self-adjusting system is intended for home and hospital use.

Source page: https://510kreport.com/device/K132606
Methodology: https://510kreport.com/methodology