# K121642: Wizard 230 Nasal Pilow Mask

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Jun 6, 2013 after 367 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090244: Swift FX, Resmed, Ltd. (2009) Summary page 1.

## Indications for use
WIZARD 230 Nasal Pillow Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP).or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, mutti-use in the hospital environment. This mask only can 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/K121642
Methodology: https://510kreport.com/methodology