Cleared Traditional

K913501 - TRACHEOSTOMY MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K913501 · B & F Medical Products, Inc. · Anesthesiology device
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Jan 1992
Decision
159d
Days
Class 1
Risk

K913501 is an FDA 510(k) clearance for the TRACHEOSTOMY MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on January 13, 1992 after a review of 159 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 B & F Medical Products, Inc. devices

Submission Details

510(k) Number K913501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1991
Decision Date January 13, 1992
Days to Decision 159 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 139d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.