Cleared Traditional

NASAL MASK, NASAL MASK, FULL FACE MASK (K133009) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K133009.
TI NASAL MASK
K140980 · Respironics, Inc. · Feb 2015
Revolution Full Face Mask
K142554 · Respironics, Inc. · Jan 2015
SIMPLE T YOUTH NASAL MASK
K140268 · Respironics, Inc. · Oct 2014
BRONCHOSCOPY ELBOW
K132168 · Respironics, Inc. · Nov 2013
REMSTAR AUTO A-FLEX HT
K131982 · Respironics, Inc. · Oct 2013
REMSTAR SE
K130077 · Respironics, Inc. · May 2013