# K132013: Swift Air

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Oct 21, 2013 after 112 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: 7 generations back to K982530 (1998). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102746: Mirage FX, Resmed, Ltd. (2010) Summary page 1.
- K090244: Swift FX, Resmed, Ltd. (2009) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K150365: Cloud9 System (2015), 0 descendants of its own

## Indications for use
The SwiftTM Air channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device. The Swift Air is: * to be used by 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/K132013
Methodology: https://510kreport.com/methodology