# K090244: Swift FX

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Apr 13, 2009 after 70 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: 5 generations back to K982530 (1998). 14 ancestors in all.
15 later devices descend from it; 7 cite it directly.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073638: Swift LT, Resmed, Ltd. (2008) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K123789: Swift FX Nano (2013), 8 descendants of its own
- K132887: Airfit N10 (2013), 7 descendants of its own
- K153673: AirFit N20 (2016), 6 descendants of its own
- K161978: AirFit N20 (2016), 5 descendants of its own
- K171212: AirFit N20 (2017), 3 descendants of its own

## Indications for use
The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift FX is: * to be used by adult patients (> 66 lb/30 kg) 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/K090244
Methodology: https://510kreport.com/methodology