# K234134: AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Pty Ltd (Registration Number: 3004604967)
- Decided: Sep 24, 2024 after 270 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: 6 generations back to K982530 (1998). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183512: Moore Park Mask, Resmed, Ltd. (2019) Summary page 5.

## Most influential descendants
- K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (2026), 0 descendants of its own

## Indications for use
AirFit F30i Mask System The AirFit F30i mask has two product variants: • AirFit F30i mask is intended for single-patent reuse in the home environment. • AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients. AirFit F30i NM Mask System The AirFit F30i Non Magnetic mask has two product variants: • The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment. • The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients. Arcadia Mask System The Arcadia has two product variants: • Arcadia mask is intended for single-patient reuse in the home environment. • Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

Source page: https://510kreport.com/device/K234134
Methodology: https://510kreport.com/methodology