# K123979: Quattro Air

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Feb 27, 2013 after 63 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K982530 (1998). 23 ancestors in all.
9 later devices descend from it; 3 cite it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063122: Mirage Quattro Full Face Mask, Resmed, Ltd. (2007) Summary page 1.
- K102746: Mirage FX, Resmed, Ltd. (2010)
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.

## Most influential descendants
- K153563: AirFit F20 (2016), 6 descendants of its own
- K170924: AirFit F20 (2018), 3 descendants of its own
- K242547: AirFit F20 Mask System; AirFit F20 NM Mask System (2025), 1 descendant of its own
- K261262: Altis Full Face Mask (2026), 0 descendants of its own
- K251847: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (2026), 0 descendants of its own

## Recalls of this device
- Jul 12, 2016 · Class II · Z-2550-2016: Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.

## Indications for use
The Quattro Air Mask System is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen) to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system. The Quattro Air Mask System is: • to be used by patients (weighing >66 lb/30 kg) for whom positive airway pressure therapy has been prescribed. • intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K123979
Methodology: https://510kreport.com/methodology