Cleared Traditional

K920573 - CANNULA NASAL OXYGEN (FDA 510(k) Clearance)

Class I Anesthesiology device.

K920573 · B & F Medical Products, Inc. · Anesthesiology device
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Aug 1992
Decision
186d
Days
Class 1
Risk

K920573 is an FDA 510(k) clearance for the CANNULA NASAL OXYGEN. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 186 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5340 - 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 K920573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date August 11, 1992
Days to Decision 186 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
47d slower than avg
Panel avg: 139d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAT Cannula, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5340
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.