Cleared Traditional

K193206 - WiZARD 510 Nasal Mask

K193206 is the FDA 510(k) clearance for WiZARD 510 Nasal Mask by Apex Medical Corp.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K193206 · Apex Medical Corp. · Anesthesiology device
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Oct 2020
Decision
344d
Days
Class 2
Risk

K193206 is an FDA 510(k) clearance for the WiZARD 510 Nasal Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Apex Medical Corp. (New Taipei City, TW). The FDA issued a Cleared decision on October 29, 2020 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Apex Medical Corp. devices

Submission Details

510(k) Number K193206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2019
Decision Date October 29, 2020
Days to Decision 344 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 140d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 266
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K193206.
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SysMed S/T
K192177 · Sysmed (China) Co., Ltd. · Nov 2020
Ventilator, Non-continuous (Respirator)
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DreamStation 2 System, DreamStation 2 Advanced System
K200480 · Respironics, Inc. · Jul 2020
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
K200089 · Fisher &Paykel Healthcare , Ltd. · Jun 2020