# K112489: Swift FX Bella

- Pathway: 510(k) (Special)
- Applicant: Resmed, Ltd.
- Decided: Dec 7, 2011 after 100 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: 6 generations back to K982530 (1998). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090244: Swift FX, Resmed, Ltd. (2009) Summary page 1.
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.
- K063122: Mirage Quattro Full Face Mask, Resmed, Ltd. (2007) Summary page 1.
- K063011: Mirage Liberty Full Face Mask, Resmed, Ltd. (2007) Summary page 1.
- K072940: Mirage Micro, Resmed, Ltd. (2007) Summary page 1.
- K073638: Swift LT, Resmed, Ltd. (2008) Summary page 1.

## Indications for use
The Swift FX Bella channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift FX Bella is: *to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. * intended for single patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K112489
Methodology: https://510kreport.com/methodology