# K041362: Resmed Hospital Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 15, 2004 after 56 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: 2 generations back to K982530 (1998). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.

## Most influential descendants
- K071149: Hri 6500, 6600 and 6700 Series V2MASKS (2008), 1 descendant of its own
- K143603: Darlinghurst Vented, Darlinghurst NV-AAV (2015), 0 descendants of its own

## Indications for use
The Hospital Full Face Mask is intended for single patient use for adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy in hospitals or clinics. This is a disposable mask. It is intended to be used for the short-term (maximum 7 days) treatment of a single patient only, then discarded.

Source page: https://510kreport.com/device/K041362
Methodology: https://510kreport.com/methodology