Cleared Traditional

K133009 - NASAL MASK

K133009 is an FDA 510(k) clearance for NASAL MASK, manufactured by BMC Medical Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K133009 · BMC Medical Co., Ltd. · Anesthesiology device
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Apr 2014
Decision
210d
Days
Class 2
Risk

K133009 is an FDA 510(k) clearance for the NASAL MASK, NASAL MASK, FULL FACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 23, 2014 after a review of 210 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 BMC Medical Co., Ltd. devices

FDA 510(k) Submission Details - K133009

510(k) Number K133009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date April 23, 2014
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 140d · This submission: 210d
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.