# K061200: Prestige Cpap Flow Generator with Prestige Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 20, 2006 after 80 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: 4 generations back to K971260 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013909: S7 Elite CP AP System, Resmed Corp (2002) Summary page 1.
- K033841: Resmed S8 Prime Cpap System, Resmed, Ltd. (2004) Summary page 1.

## Indications for use
The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.

Source page: https://510kreport.com/device/K061200
Methodology: https://510kreport.com/methodology