# K193206: WiZARD 510 Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Oct 29, 2020 after 344 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: 4 generations back to K833786 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103174: Apex Medical Wizard Series Cpap Mask, Apex Medical Corp. (2011) Summary page 4.

## Indications for use
WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

Source page: https://510kreport.com/device/K193206
Methodology: https://510kreport.com/methodology