Cleared Traditional

K894369 - APDYNE PHENOL APPLICATOR KIT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K894369 · Apdyne Medical Co. · Ear, Nose, Throat device
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Oct 1989
Decision
90d
Days
Class 1
Risk

K894369 is an FDA 510(k) clearance for the APDYNE PHENOL APPLICATOR KIT. Classified as Applicator, Ent (product code KCJ), Class I - General Controls.

Submitted by Apdyne Medical Co. (Saint Paul, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 90 days - within the typical 510(k) review window.

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. 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 Apdyne Medical Co. devices

Submission Details

510(k) Number K894369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 14, 1989
Decision Date October 12, 1989
Days to Decision 90 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
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCJ Applicator, Ent
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.