# K103174: Apex Medical Wizard Series Cpap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: May 6, 2011 after 191 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: 3 generations back to K833786 (1983). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000705: Respironics Silhouette Nasal Mask, Models 1003224 and 1003223, Respironics, Inc. (2000) Summary page 1.
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.
- K961915: Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- K182394: WiZARD 310/320 Series CPAP Mask (2019), 1 descendant of its own
- K243023: WiZARD 520 Full Face Mask (2025), 0 descendants of its own
- K193206: WiZARD 510 Nasal Mask (2020), 0 descendants of its own

## Indications for use
WIZARD 210/220 series OPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (OPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CRAP or bi-level system) has been prescribed.

Source page: https://510kreport.com/device/K103174
Methodology: https://510kreport.com/methodology