Cleared Traditional

K902896 - 49-610 NIKO-NOSE FIXATION TAPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K902896 · Nikomed U.S.A., Inc. · Anesthesiology device
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Oct 1990
Decision
112d
Days
Class 1
Risk

K902896 is an FDA 510(k) clearance for the 49-610 NIKO-NOSE FIXATION TAPE. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Nikomed U.S.A., Inc. (North Brunswick, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 Nikomed U.S.A., Inc. devices

Submission Details

510(k) Number K902896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date October 23, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 139d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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.