# K042403: Mirage Swift

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Oct 8, 2004 after 35 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: 3 generations back to K982530 (1998). 11 ancestors in all.
80 later devices descend from it; 9 cite it directly.
8 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032433: Nasal Jacks Mask, Resmed, Ltd. (2003) Summary page 1.
- K980721: Sullivan Autoset, Resmed, Ltd. (1998) Summary page 1.
- K032916: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K023306: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K023284: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.

## Most influential descendants
- K063122: Mirage Quattro Full Face Mask (2007), 38 descendants of its own
- K072940: Mirage Micro (2007), 26 descendants of its own
- K063036: Opus HC482 Direct Nasal Mask (2006), 24 descendants of its own
- K102746: Mirage FX (2010), 19 descendants of its own
- K073638: Swift LT (2008), 17 descendants of its own

## Indications for use
The Mirage Swift is intended for Multiple Patient Reuse by adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy for use in home, hospitals or clinics.

Source page: https://510kreport.com/device/K042403
Methodology: https://510kreport.com/methodology