Cleared Traditional

WiZARD 520 Full Face Mask

K243023 · Wellell, Inc. · Anesthesiology

May 2025

Decision

238d

Days

Class 2

Risk

About This 510(k) Submission

K243023 is an FDA 510(k) clearance for the WiZARD 520 Full Face Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Wellell, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on May 23, 2025, 238 days after receiving the submission on September 27, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K243023 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	May 23, 2025
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF