# K132901: Airsoft F15

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jun 9, 2014 after 266 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: 8 generations back to K982530 (1998). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123979: Quattro Air, Resmed, Ltd. (2013) Summary page 1.
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.

## Indications for use
The AirSoft F15 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as continuous positive airway pressure (CPAP) or bilevel system. The AirSoft F15 is: * to be used by patients (weighing >66 lb (30 kg)) for whom positive airway pressure therapy has been prescribed * intended for single-patient reuse in the home environment and multipatient reuse in the hospital/institutional environment.

Source page: https://510kreport.com/device/K132901
Methodology: https://510kreport.com/methodology