# K040566: Resmed Hospital Nasal Mask

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Apr 2, 2004 after 29 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: 1 generation back to K961783 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.

## Indications for use
The Hospital Nasal Mask is an accessory to a non-continuous ventilator (Respirator) intended for single patient, multi-use for adults prescribed continuous positive airway pressure (CPAP) or Bilevel therapy in hospitals or.clinics. This is a disposable mask. It is, intended to be used for the short-term (7 days) treatment of a single patient only, then discarded.

Source page: https://510kreport.com/device/K040566
Methodology: https://510kreport.com/methodology