Cleared Traditional

K103174 - APEX MEDICAL WIZARD SERIES CPAP MASK

K103174 is an FDA 510(k) clearance for APEX MEDICAL WIZARD SERIES CPAP MASK, manufactured by Apex Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K103174 · Apex Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
191d
Days
Class 2
Risk

K103174 is an FDA 510(k) clearance for the APEX MEDICAL WIZARD SERIES CPAP MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on May 6, 2011 after a review of 191 days - an extended review cycle.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K103174

510(k) Number K103174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2010
Decision Date May 06, 2011
Days to Decision 191 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
51d slower than avg
Panel avg: 140d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 306
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K103174.
INFOSEND GSM
K110316 · Fisher &Paykel Healthcare , Ltd. · Aug 2011
TRUBLUE NASAL MASK
K110405 · Respironics, Inc. · Jun 2011
IQ VENTILATION NASAL MASK
K102317 · Sleepnet Corporation · May 2011
PERFORMAX TOTAL FACE MASK
K103395 · Respironics, Inc. · Mar 2011
ZEST PETITE NASAL MASK
K103786 · Fisher &Paykel Healthcare , Ltd. · Mar 2011
S9 VPAP ADAPT WITH H5I
K102586 · Resmed, Ltd. · Mar 2011