# K132887: Airfit N10

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Dec 20, 2013 after 95 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K982530 (1998). 34 ancestors in all.
7 later devices descend from it; 1 cites it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123789: Swift FX Nano, Resmed, Ltd. (2013) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837, Sleepnet Corporation (2006) Summary page 1.

## Most influential descendants
- 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
- K180497: Scone Mask (2018), 1 descendant 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
- Nov 20, 2023 · Class I · Z-0536-2024: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/ob

## Indications for use
The AirFit N10 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 AirFit N10 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/K132887
Methodology: https://510kreport.com/methodology