# K243023: WiZARD 520 Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Wellell, Inc.
- Decided: May 23, 2025 after 238 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: 5 generations back to K833786 (1983). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182394: WiZARD 310/320 Series CPAP Mask, Apex Medical Corp. (2019) Summary page 5.

## Indications for use
The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment. The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.

Source page: https://510kreport.com/device/K243023
Methodology: https://510kreport.com/methodology