Cleared Traditional

K920357 - ULTRACELL EAR WICK

K920357 is an FDA 510(k) clearance for ULTRACELL EAR WICK, manufactured by Ultracell Medical Technologies, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KCN cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K920357 · Ultracell Medical Technologies, Inc. · Ear, Nose, Throat device
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Feb 1993
Decision
371d
Days
Class 1
Risk

K920357 is an FDA 510(k) clearance for the ULTRACELL EAR WICK. Classified as Ear Wick (product code KCN), Class I - General Controls.

Submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - 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. Elevated predicate reliance profile. 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 Ultracell Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K920357

510(k) Number K920357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date February 01, 1993
Days to Decision 371 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 89d · This submission: 371d
Pathway characteristics
Predicate-based equivalence.

KCN Device Classification - Class 1, General Controls

Product Code KCN Ear Wick
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.