Cleared Traditional

POST-AID (K840907) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K840907 · E.W. Link, Inc. · Ear, Nose, Throat device
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Aug 1984
Decision
156d
Days
Class 1
Risk

K840907 is an FDA 510(k) clearance for the POST-AID. Classified as Dropper, Ent (product code KCM), Class I - General Controls.

Submitted by E.W. Link, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 156 days - an extended review cycle.

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 E.W. Link, Inc. devices

Submission Details

510(k) Number K840907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1984
Decision Date August 02, 1984
Days to Decision 156 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
67d slower than avg
Panel avg: 89d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCM Dropper, 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.