Cleared Traditional

K902420 - CATHETER, NASAL, OXYGEN (FDA 510(k) Clearance)

Class I Anesthesiology device.

K902420 · Gainor Medical Europe, Ltd. · Anesthesiology device
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Apr 1991
Decision
321d
Days
Class 1
Risk

K902420 is an FDA 510(k) clearance for the CATHETER, NASAL, OXYGEN. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Gainor Medical Europe, Ltd. (Mcdonough, US). The FDA issued a Cleared decision on April 17, 1991 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gainor Medical Europe, Ltd. devices

Submission Details

510(k) Number K902420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1990
Decision Date April 17, 1991
Days to Decision 321 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 139d · This submission: 321d
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.