Class Class II
WiZARD 520 Full Face Mask (K243023)
Description
WiZARD 520 Full Face Mask by Wellell, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243023
Clearance Date2025-05-23
Clearance TypeTraditional
Product CodeBZD
Regulation Number868.5905
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243023
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. WiZARD 520 Full Face Mask (K243023) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182394 | WiZARD 310/320 Series CPAP Mask | Apex Medical Corp. | 2019 |
Trace the full predicate network for K243023
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.