Cleared Traditional

INNOVATIONS NASAL TAMPON (K896248) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K896248 · Innovations by Necessity, Inc. · Ear, Nose, Throat device
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Apr 1990
Decision
165d
Days
Class 1
Risk

K896248 is an FDA 510(k) clearance for the INNOVATIONS NASAL TAMPON. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Innovations by Necessity, Inc. (Corona Del Mar, US). The FDA issued a Cleared decision on April 13, 1990 after a review of 165 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovations by Necessity, Inc. devices

Submission Details

510(k) Number K896248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date April 13, 1990
Days to Decision 165 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 89d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
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.